What Does Peg Stand For In Cosmetics?
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INTRODUCTION – Polyethylene glycols (PEGs) are composed of polyether compounds repeating ethylene glycol units according to the constituent monomer or parent molecule (as ethylene glycol, ethylene oxide, or oxyethylene) ( Fig.1 ). Most PEGs are commonly available commercially as mixtures of different oligomer sizes in broadly- or narrowly-defined molecular weight (MW) ranges.
For instance, PEG-10,000 typically designates a mixture of PEG molecules (n = 195 to 265) having an average MW of 10,000. PEG is also known as polyethylene oxide (PEO) or polyoxyethylene (POE), with the three names being chemical synonyms. However, PEGs mainly refer to oligomers and polymers with molecular masses below 20,000 g/mol, while PEOs are polymers with molecular masses above 20,000 g/mol, and POEs are polymers of any molecular mass.
Relatively small molecular weight PEGs are produced by the chemical reaction between ethylene oxide and water or ethylene glycol (or other ethylene glycol oligomers), as catalyzed by acidic or basic catalysts. To produce PEO or high-molecular weight PEGs, synthesis is performed by suspension polymerization. Polimerization of ethylene glycol. PEGs, together with their derivatives, do not have definite chemical entities, rather, they are compound mixtures having different chain lengths. PEGs are used in cosmetics “as is” or in combination with their derivatives in which their 2 terminal primary hydroxyl groups can create mono-, di- and poly-esters, amines, ethers and acetals.
Furthermore, PEGs can create additional compounds and complexes through a reaction in their ether bridges. Overall, PEG derivatives may include PEG ethers (e.g. laureths, ceteths, ceteareths, oleths, and PEG ethers of glyceryl cocoates), PEG fatty acids (e.g. PEG laurates, dilaurates, stearates, and distearates), PEG castor oils, PEG amine ethers (PEG cocamines), PEG propylene glycols, and other derivates (e.g., PEG soy sterols and PEG beeswax).
Since many PEG types are hydrophilic, they are favorably used as penetration enhancers, especially in topical dermatological preparations (2), Polyethylene glycols (PEGs) and their derivatives are widely used in cosmetics as surfactants, cleansing agents, emulsifiers, skin conditioners, and humectants.
Adding to their use in cosmetics, many PEG compounds also have other applications. Available information from these uses is included in this assessment where relevant. In the pharmaceutical industry, for instance, they are used as ointment bases or vehicles for drugs in capsules, tablet and pill binders, suppositories, and liquid prescriptions; and in veterinary drugs as part of parenteral, topical, ophthalmic, oral, and rectal preparations.
Further various applications were found in soaps and detergents, wood preservation, printing, chemical mixtures, as well as in industries that produces textiles, leather, plastics, resins, paper, ceramics, glass, rubber, petroleum, and metal. Polyoxyethylene sorbitan esters (polysorbates) and polyethylene glycol, with an average molecular weight of 6,000, are permitted as food additives in various food products (3, 4),
- In previous studies, PEGs and various PEG compounds have been reviewed and assessed well to be concluded as relatively safe for use in cosmetics under the present conditions of intended use (3, 5, 6),
- However, all PEG compounds were not covered in the previous studies due to their wide variety, and the introduction of new entities currently used in cosmetics suggests supplementary evaluation.
Thus, it is essential to continuously monitor the safety and risks of PEG-derived products being exposed to consumers using cosmetic products to ensure that no potential health threats will arise, especially when used extensively and chronically. In this review, we searched for and enumerated the PEG polymers and their derivatives that are used in cosmetics ( Table 1 ) in order to evaluate the safety of their application according to the currently available information in the literature.
Is PEG safe for skin?
What is most notable about the various forms of PEG studied to date is they have been shown to be non-irritating for skin or eyes, even when used in concentrations greater than what most skin care products contain. PEGs also widely considered non-toxic because they do not penetrate intact skin.
What is the use of PEG in cosmetics?
Abstract – Polyethylene glycols (PEGs) are products of condensed ethylene oxide and water that can have various derivatives and functions. Since many PEG types are hydrophilic, they are favorably used as penetration enhancers, especially in topical dermatological preparations.
- PEGs, together with their typically nonionic derivatives, are broadly utilized in cosmetic products as surfactants, emulsifiers, cleansing agents, humectants, and skin conditioners.
- The compounds studied in this review include PEG/PPG-17/6 copolymer, PEG-20 glyceryl triisostearate, PEG-40 hydrogenated castor oil, and PEG-60 hydrogenated castor oil.
Overall, much of the data available in this review are on PEGylated oils (PEG-40 and PEG-60 hydrogenated castor oils), which were recommended as safe for use in cosmetics up to 100% concentration. Currently, PEG-20 glyceryl triisostearate and PEGylated oils are considered safe for cosmetic use according to the results of relevant studies.
What does PEG mean in pharmaceutical industry?
PEF: Peak expiratory flow.
Is PEG 100 safe for skin?
Safety Profile of PEG-100 STEARATE – PEG-100 Stearate is safe to be used on skin and hair. It is sometimes considered carcinogenic because the manufacturing process leaves behind a residue known as 1,4-dioxane that has been linked to uterine and breast cancers.
Are PEGs banned in Europe?
Synthetic liquid propylene glycol is banned in Europe, but it’s still commonly used in the U.S. This is just one example of how U.S. chemical regulations pale in comparison to Europe. For some reason, many toxic chemicals in the U.S. remain unregulated and under-researched.
Is PEG toxic to humans?
Abstract – Polyethylene glycols (PEGs) are products of condensed ethylene oxide and water that can have various derivatives and functions. Since many PEG types are hydrophilic, they are favorably used as penetration enhancers, especially in topical dermatological preparations.
PEGs, together with their typically nonionic derivatives, are broadly utilized in cosmetic products as surfactants, emulsifiers, cleansing agents, humectants, and skin conditioners. The compounds studied in this review include PEG/PPG-17/6 copolymer, PEG-20 glyceryl triisostearate, PEG-40 hydrogenated castor oil, and PEG-60 hydrogenated castor oil.
Overall, much of the data available in this review are on PEGylated oils (PEG-40 and PEG-60 hydrogenated castor oils), which were recommended as safe for use in cosmetics up to 100% concentration. Currently, PEG-20 glyceryl triisostearate and PEGylated oils are considered safe for cosmetic use according to the results of relevant studies.
What is a natural alternative to PEG?
Texture agents – The PHYTOWAX range of natural waxes offers a multitude of cosmetic applications: sunscreens, facials, hair care, make-up, baby care, and more. VEGELINE 65 and VEGELINE 70 are two 100% natural alternatives to petroleum jelly, petrolatum and paraffins.
What is alternative to PEG?
4.2. Zwitterionic Polymers – Synthetic zwitterionic materials such as poly(carboxybetaine) (pCB) and poly(sulfobetaine) (pSB) ( Figure 7 ) have been proposed as PEG alternatives due to their strong hydration, conferring high resistance to nonspecific protein fouling in addition to their inherently low immunogenicity,
Yang et al. demonstrated that zwitterionic poly(carboxybetaine acrylamide) (pCBAA) modified gold NPs (GNPs) did not absorb serum proteins nor induce agglomeration, as compared to the significant fouling and aggregation elicited by PEG (5 kDa) coated GNPs (PEG-GNPs) and oligo(ethylene glycol) methacrylate (OEGMA) coated GNPs (OEGMA-GNPs).
Consequently, pCBAA-GNPs were found to be more stable in the bloodstream and thus had a longer circulation time than that of PEG-GNPs and OEGMA-GNPs, The immunogenicity of pCBAA-GNPs compared to PEG-GNPs, however, was not investigated in this study. Chemical structures of some zwitterionic polymers. The prevention of protein absorption is paramount to decreasing opsonization that leads to immune recognition and the clearance of therapeutic agents. Jiang et al. summarized the enhanced anti-fouling properties of zwitterionic materials, in addition to various methods for the functionalization of these materials to a myriad of surfaces towards biomedical applications,
The authors concluded that zwitterionic materials, as the next generation of biomaterials, open new avenues for the design and synthesis of anti-fouling agents for therapeutic drug delivery. Zhang et al. interrogated an alternative stealth material consisting of polypeptides with a high zwitterion density (PepCB) ( Figure 8 a) by utilizing uricase as a model protein to examine the different pharmacokinetic and immunological profiles of uricase-modified PepCB and PEGylated uricase in rats in vivo,
After 24 and 72 h, free uricase underwent rapid clearance from circulation, while the uricase-modified PepCB and PEGylated uricase showed sustained activity, with the uricase-modified PepCB achieving the longest half-life. This phenomenon was likely due to the stronger hydration effect of carboxybetaine groups in comparison to ethylene glycol units, highlighting the advantageous properties of zwitterionic PepCB over conventional PEG, Chemical structure of the zwitterionic carboxybetaine functionalized polypeptide (PepCB) ( a ). The preparation of poly(2-methacryloyloxyethyl phosphorylcholine)/poly(β-amino ester) (PMPC/PAE) mixed shell micelles (MSMs) with pH-sensitive behavior: MSMs were in zwitterionic state at a physiological blood pH (7.4) and in a cationic form within the tumor microenvironment (pH 6.5) ( b ).
Positing that zwitterionic materials have been found to be superior to PEG for overcoming undesirable immune responses after administration, Ou et al. designed poly(2-methacryloyloxyethyl phosphorylcholine) (PMPC)/poly(β-amino ester) (PAE) modified poly(ε-caprolactone) (PCL) micelles to form a mixed-shell micelles (MSMs) ( Figure 8 b) in order to evaluate their in vivo circulation and determine anti-polymer antibody production,
Single PEG-PCL micelles (PEGSMs) and single PMPC-PCL micelles (PMPCSMs) were utilized as controls. After intravenous administration in a rat model, MSMs with the optimal hydrophilic:hydrophobic ratio of 1:1 achieved the highest blood retention time. Furthermore, PEGSMs were degraded in the blood much faster than PMPCSMs and MSMs, as has been observed with other PEGylation-based therapeutic approaches.
Han et al. recently demonstrated the remarkable properties of zwitterionic polymers in protein modification by utilizing zwitterlated interferon alpha-2a as an alternative therapeutic candidate to PEGylated interferon alpha-2a. A prolonged circulation time and a reduced ABC was observed after repeated injections of zwitterlated interferon alpha-2a compared to the PEGylated agent, and, importantly, zwitterlation could mitigate interferon alpha-2a bioactivity loss in vitro over PEGylated interferon alpha-2a,
Overall, zwitterionic polymers hold great promise as PEG alternatives, but their application remains limited, likely due to difficulties regarding their synthesis and conjugation. Through many research efforts to evaluate synthetic and natively-derived polymers as alternative candidates to PEG, the polymers PG, polyaminoacids, polyacrylamides, PVP, zwitterionic polymers, and polysaccharides have shown an analogous or improved performance compared to PEG and/or PEGylated materials ( Table 1 ),
Does ibuprofen contain PEG?
Abstract – The solubility of ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID), is enhanced by synthesizing ibuprofen ester with a water-soluble polymer, poly(ethylene glycol) (PEG), and the product obtained functions as a nonionic surfactant (IBF-PEG800, IP800). The morphology and aggregation behavior of IP800 micelles and IP800/PEG complexes in aqueous solution are investigated by (1)H NMR technology, dynamic light scattering (DLS), isothermal titration calorimetry (ITC), and fluorescence resonance energy transfer (FRET). The microstructure of IP800 micelles is strongly related to the concentration of IP800. IP800 monomers can form looser micelles at relatively low concentrations and much tighter micelles at high concentrations. And the binding model of PEG with looser IP800 micelles dramatically depends on the molecular weight and concentration of PEG: PEG with lower molecular weight (MW 2000 Da) binds to the surface of IP800 micelles, and one long PEG chain (6000 < MW < or = 20000 Da) wraps several IP800 micelles. Besides, the ratio of short chain PEG400 to IP800 micelles of the IP800/PEG complex is about 15:1 at a fixed concentration of IP800 (0.05 mM), and for the long chain PEG20000 it is 1:3-1:4.
What is PEG called in English?
Peg noun (HOOK) a small stick or hook that sticks out from a surface and from which objects, especially clothes, can hang : He took off his coat/hat and hung it on the peg.
Is PEG bad in makeup?
POLYETHYLENE GLYCOLS – One of the ingredients you might want to stay away from is polyethylene glycols (PEGs). PEGs are synthetic petrochemicals commonly used in skincare and hair color products as thickeners, softeners, and solvents. They help enhance the absorption of ingredients into the skin, including the harmful ones.
- Why avoid them: It has been found that PEGs contain impurities, which include ethylene oxide and 1,4-dioxane.
- These two are known carcinogens and respiratory irritants.
- Long-term exposure to ethylene oxide can cause serious health consequences, including damage to the nervous system.
- In fact, this chemical was used as nerve gas in World War I.
Another concern about PEGs is their penetration enhancement effects, and is why we recommend avoiding PEGs in your hair color products. However, there are also studies claiming PEGs with a molecular weight of 200 to over 10,000 are considered harmless, as long as they are not applied to damaged skin.2 But why bother when there are many products out there that are PEG-free?
What is PEG toxic?
The Big Question – We know the question on your mind is “are PEGs toxic?”. Unfortunately, there is no simple answer here. It depends on a variety of factors which we will outline below. The molecule itself, (Poly)ethylene Glycol, is considered inert, non-toxic, and generally considered safe for all usages.
The FDA classifies PEGs as Generally Recognized as Safe (GRAS) ingredients for both food and cosmetic production. However, the process of making PEGs creates toxic byproducts. Additionally, its starting materials are highly toxic to humans and are known to have carcinogenic properties. These include Ethylene Oxide, 1,4-dioxane, and other raw materials,
The concern around PEGs stems from fears of contamination with heavy metals ions, trace elements of the raw materials, and other toxic substances. One way that companies prevent this from happening is by sourcing PEGs from reputable manufacturers, who ensures that no trace of the impurities can be found from the get-go.
In Canada for example, Ethylene Glycol and 1,4-dioxane are on the Prohibited Cosmetic Hotlist, however, when they are considered impurities or potential contaminants, the hotlist does not apply. But how, as consumers, may we actually know the truth? Simply put, there is no way to know how a company is sourcing their raw materials so you may consider avoiding products with PEGs entirely.
There are also environmental concerns regarding petroleum-derived PEGs; specifically their low biodegradability and potential ability to build up in bodies of water. Since most of our cosmetic products eventually end up down the drain, there are concerns that PEGs may be accumulating in rivers, lakes, and oceans as the filtration process cannot catch these polymers.
Is PEG 100 vegan?
Is PEG-100 Stearate Vegan? Polyethylene Glycol -100 stearate may or may not be vegan. One of its source inputs, stearic acid, can be animal-derived.
Is PEG a plastic?
What are PEGs? You have probably noticed that many of cosmetics and personal care products you use have different types of PEGs among ingredients. PEG, which is the abbreviation of polyethylene glycol, is not a definitive chemical entity in itself, but rather a mixture of compounds, of polymers that have been bonded together.
- Polyethylene is the most common form of plastic, and when combined with glycol, it becomes a thick and sticky liquid.
- PEGs are almost often followed by a number, for example PEG-6, PEG-8, PEG-100 and so on.
- This number represents the approximate molecular weight of that compound.
- Typically, cosmetics use PEGs with smaller molecular weights.
The lower the molecular weight, the easier it is for the compound to penetrate the skin. Often, PEGs are connected to another molecule. You might see, for example, PEG 100 stearate as an ingredient. This means that the polyethylene glycol polymer with an approximate molecular weight of 100 is attached chemically to stearic acid.
- In cosmetics, PEGs function in three ways: as emollients (which help soften and lubricate the skin), as emulsifiers (which help water-based and oil-based ingredients mix properly), and as vehicles that help deliver other ingredients deeper into the skin.
- What effect do PEGs have on your skin? Polyethylene glycol compounds have not received a lot of attention from consumer groups but they should.
The most important thing to know about PEGs is that they have a penetration enhancing effect, the magnitude of which is dependent upon a variety of variables. These include: both the structure and molecular weight of the PEG, other chemical constituents in the formula, and, most importantly, the overall health of the skin.
PEGs of all sizes may penetrate through injured skin with compromised barrier function. So it is very important to avoid products with PEGs if your skin is not in best condition. Skin penetration enhancing effects have been shown with PEG-2 and PEG-9 stearate. This penetration enhancing effect is important for three reasons: 1) If your skin care product contains a bunch of other undesirable ingredients, PEGs will make it easier for them to get down deep into your skin.2) By altering the surface tension of the skin, PEGs may upset the natural moisture balance.3) PEGs are not always pure, but often come contaminated with a host of toxic impurities.
Impurities and other PEG risks According to a report in the International Journal of Toxicology by the cosmetic industry’s own Cosmetic Ingredient Review (CIR) committee, impurities found in various PEG compounds include ethylene oxide; 1,4-dioxane; polycyclic aromatic compounds; and heavy metals such as lead, iron, cobalt, nickel, cadmium, and arsenic.
Many of these impurities are linked to cancer. PEG compounds often contain small amounts of ethylene oxide. Ethylene oxide (found in PEG-4, PEG-7, PEG4-dilaurate, and PEG 100) is highly toxic — even in small doses — and was used in World War I nerve gas. Exposure to ethylene glycol during its production, processing and clinical use has been linked to increased incidents of leukemia as well as several types of cancer.
Finally, there is 1,4-dioxane (found in PEG-6, PEG-8, PEG-32, PEG-75, PEG-150, PEG-14M, and PEG-20M), which, on top of being a known carcinogen, may also combine with atmospheric oxygen to form explosive peroxides — not exactly something you want going on your skin.
Even though responsible manufacturers do make efforts to remove these impurities (1,4-dioxane that can be removed from cosmetics through vacuum stripping during processing without an unreasonable increase in raw material cost), the cosmetic and personal care product industry has shown little interest in doing so.
Surprisingly, PEG compounds are also used by natural cosmetics companies. If you find PEGs in your cosmetics Although you might find conflicting information online regarding Polyethylene Glycol, PEGs family and their chemical relatives, it is something to pay attention to when choosing cosmetic and personal care products.
If you have sensitive or damaged skin it might be a good idea to avoid products containing PEGs. Using CosmEthics app you can easy add PEGs to personal alerts,In our last blog post we wrote about vegan ingredients. Natural glycols are a good alternative to PEGs, for example natural vegetable glycerin can be used as both moisturiser and emulsifier. CosmEthics vegan list can help you find products that use vegetable glycerin as wetting agent.At present, there is not enough information shown on product labels to enable you to determine whether PEG compounds are contaminated. But if you must buy a product containing PEGs just make sure that your PEGs are coming from a respected brand.
Stay healthy! CosmEthics Team Download CosmEthics app for iOS in Europe. References: Black, R.E., et al. “Occurrence of 1,4-dioxane in cosmetic raw materials and finished cosmetic products.” J AOAC Int2001 ;84(3):666–670. Johnson, W., Jr. & Cosmetic Ingredient Review Expert Panel.
“Final report on the safety assessment of PEG-25 propylene glycol stearate, PEG-75 propylene glycol stearate, PEG-120 propylene glycol stearate, PEG-10 propylene glycol, PEG-8 propylene glycol cocoate, and PEG-55 propylene glycol oleate.” Int J Toxicol, 2001 ;20 (Suppl 4):13–26. Scalia, S. & Menegatti, E.
“Assay of 1,4-dioxane in commercial cosmetic products by HPLC.” Farmaco, 1991 ;46(11):1365–1370. Stolley, P. “A preliminary report of cancer incidence in a group of workers potentially exposed to ethylene oxide.” Clinical Epidemiology Unit, University of Pennsylvania School of Medicine, April 25, 1986.
Is polyethylene glycol cancerous?
Abstract – Dietary polyethylene-glycol (PEG) 8000, a nonfermented polymer laxative, strongly suppresses azoxymethane-induced aberrant crypt foci (ACF) in the colon of rats, as shown in a previous study (D.E. Corpet et al., Carcinogenesis (Lond.), 20: 915-918, 1999). In the present study, we tested the effect of PEG administered during either initiation or postinitiation, the dose-response effect of PEG, the regressive effect of PEG on established ACF, and the preventive effect of PEG on colon cancers in rats. The general design was to initiate carcinogenesis in F344 rats by a single injection of azoxymethane (20 mg/kg) and to randomize the animals 7 days later to AIN-76 diets containing 5% PEG or no PEG (control). At termination, ACF and tumors were scored blindly by a single observer. The administration of 5% PEG for 32 days to groups of 10 female rats in either food or drinking water reduced the number of ACF by a factor of 8 (P = 0.0002) and reduced the number of large ACF by a factor of 20-30 (P = 0.002). No protection was afforded when PEG was given only during the initiation phase. Diets containing 0%, 0.5%, 2%, or 5% PEG fed for 35 days to four groups of male rats inhibited ACF in a dose-dependent manner (P < 0.0001). The administration of a 5% PEG diet for 41 days, starting 42 days after carcinogen injection, led to a 73% decrease in the number of ACF (P < 0.0001). Dietary PEG thus caused the regression of established ACF. Macroscopic tumors were evaluated by histology in rats that had been fed a high-fat diet containing cooked casein to promote tumor growth for 81 days. In this accelerated model of carcinogenesis, dietary PEG suppressed the occurrence of colon adenomas and carcinomas: the incidence of tumors decreased from 70% to 10% (P = 0.005); and the multiplicity decreased from 2.1 to 0.1 tumor(s)/rat (P = 0.003). No cancer was detected in the PEG-fed rats. Taken together, these results suggest that PEG could be a potent anticancer agent in the postinitiation phase of carcinogenesis. Because PEG is a substance that is generally recognized as safe (GRAS list, Food and Drug Administration), its cancer-preventive features could be tested in humans.
Is PEG 40 carcinogenic?
Health and Environmental Hazards – Depending on manufacturing processes, PEG s may be contaminated with measurable amounts of ethylene oxide and 1,4-dioxane. i The International Agency for Research on Cancer classifies ethylene oxide as a known human carcinogen and 1,4-dioxane as a possible human carcinogen.
- Ethylene oxide can also harm the nervous system ii and the California Environmental Protection Agency has classified it as a developmental toxicant based on evidence that it may interfere with human development.
- Iii 1,4-dioxane is also persistent.
- In other words, it doesn’t easily degrade and can remain in the environment long after it is rinsed down the shower drain.1,4-dioxane can be removed from cosmetics during the manufacturing process by vacuum stripping, but there is no easy way for consumers to know whether products containing PEG s have undergone this process.
iv In a study of personal care products marketed as “natural” or “organic” (uncertified), U.S. researchers found 1,4-dioxane as a contaminant in 46 of 100 products analyzed. v While carcinogenic contaminants are the primary concern, PEG compounds themselves show some evidence of genotoxicity vi,vii and if used on broken skin can cause irritation and systemic toxicity.
Who should not use PEG?
PEG 3350 should be used with caution in patients with certain medical problems including but not limited to electrolyte imbalances, renal dysfunction, seizure disorders or with certain gastrointestinal problems including gastrointestinal obstruction, toxic megacolon, or bowel perforation.
Is PEG safe for sensitive skin?
Safety Profile of PEG-8 – Although PEG-8 is considered safe for topical use on healthy skin when used in limits, it may be contaminated with ethylene oxide, 1,4-dioxane which can bring in toxicity. PEG-8 should not be used on sensitive skin.
Is PEG toxic to cells?
Abstract – Polyethylene glycol (PEG) derivatives have been widely used in bio-related research. However, PEG oligomers (with different molecular weights) or PEG based monomers (with different chain end groups) actually have different chemical and physical properties, which might lead to potential toxicity.
In this work, the cytotoxicity of a series of PEG derivatives (oligomers and monomers) has been measured using human cervical cancer cells (HeLa) and a cell line of fibroblasts derived from mice (L929) as model cells. Most of the PEG oligomers are safe to both types of cells except triethylene glycol (TEG), which is toxic at high concentrations to L929 cells.
On the other hand, PEG-based monomers including poly(ethylene glycol) methyl ether acrylate (mPEGA) and poly(ethylene glycol) methyl ether methacrylate (mPEGMA) showed obvious cytotoxicity. Subsequently, those toxic PEG derivatives have been studied to reveal the different mechanisms of their toxicity.
Does PEG clog pores?
6. Polyethylene glycol – Polyethylene glycol, also known as PEG, is put in facial products to stabilize them, add emolliency and to help other ingredients penetrate. The PEG found is skincare products is a thick sticky substance that can clog pores. Ingredients composed of PEG to be avoided include PEG 100 Distearate, PEG 150 Distearate, PEG 100 Stearate, PEG 16 Lanolin, PEG 20 Stearate, PEG 20 Stearate, PEG 200 Dilaurate, and PEG 8 Stearate.
Who should not use PEG?
PEG 3350 should be used with caution in patients with certain medical problems including but not limited to electrolyte imbalances, renal dysfunction, seizure disorders or with certain gastrointestinal problems including gastrointestinal obstruction, toxic megacolon, or bowel perforation.