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Petrolatum (also known as petroleum jelly and white petrolatum) occurs as a colorless or pale yellow semisolid. It was originally promoted as a topical ointment for its healing properties. After petroleum jelly became a medicine cabinet staple, consumers began to use it for a myriad of ailments and cosmetic purposes, including toenail fungus, nosebleeds, diaper rash, and chest colds. While modern developments in science have created a more thorough understanding of petrolatum’s medicinal value, the U.S. Food and Drug Administration (FDA) still approves of its use as an over-the-counter (OTC) skin protectant, as well as in other ophthalmic and anorectal OTC drug products.
In cosmetics and personal care products, petrolatum is used in the formulation of a variety of product types, including bath products, cleansing products, skin care products, makeup, shampoos, permanent waves, hair conditioners, shaving products, and suntan products. As an OTC drug petrolatum, it can also be used to temporarily protect injured or exposed skin from harmful or annoying external sources that cause rashes and scratches while also providing relief to the skin. Furthermore, petrolatum slows the transepidermal water loss (TEWL) from the skin by forming a barrier on the skin's surface. It enhances the appearance and feel of hair, by increasing hair body, suppleness, or sheen, or by improving the texture of hair that has been damaged physically or by chemical treatment.
There is a common misconception that petrolatum and glycerin react similarly and exhibit the same properties. However, they are not the same. Petrolatum is hydrophobic (i.e., water-repelling) and insoluble in water. It acts by forming a protective barrier that traps moisture in the skin. Glycerin, on the other hand, is strongly hydrophilic (i.e., water-attracting). By absorbing moisture from the air, glycerin acts to moisturize the skin. Glycerin thus produces the feeling of wetness on the skin.
Petrolatum is one of the main treatments dermatologists recommend for dry skin. The American Academy of Dermatology recommends that “If your skin is dry, look for a product that contains petrolatum or lanolin, which can seal moisture into your skin.”
Petrolatum, or white petrolatum, belongs to a class of chemicals referred to as hydrocarbons, a group of compounds containing only carbon and hydrogen. Hydrocarbons are generally derived from petroleum, but some of them are also found naturally in the plant and animal kingdom. While the source of petrolatum (petroleum) often leads to criticism of its use, one must remember that the great majority of consumer products used worldwide, including plastic bottles and ink pens to automobile tires, telephones, and fabrics are all prepared from petroleum. The petrolatum used in cosmetic products is extracted and purified from the petroleum, not unlike the extraction and purification of vegetable oils. Whereas vegetable oils are often obtained from solid materials, white mineral oil is obtained from a liquid source. The petrolatum used in cosmetic and personal care products is a very highly refined, purified form of the ingredient. The purity of cosmetic grade petrolatum is also evident from its allowed uses in the U.S. as OTC skin protectant, and in OTC ophthalmic and anorectal drugs.
The Food and Drug Administration (FDA) permits the use of Petrolatum as a multipurpose additive for direct addition to food. Petrolatum is also an approved indirect food additive. For example, it may be used as a defoaming agent and it may be used in adhesives in contact with food. Petrolatum is also approved as an active ingredient in Over-the-Counter (OTC) skin protectant drug products as well as in ophthalmic, and anorectal drug products. The Cosmetic Ingredient Review (CIR) has deferred evaluation of this ingredient because the safety has been assessed by FDA. This deferral of review is according to the provisions of the CIR Procedures.
FDA permits the use of petrolatum as a multipurpose additive for direct addition to food. Petrolatum is also an FDA-approved indirect food additive. For example, it may be used as a defoaming agent and it may be used in adhesives in contact with food.
Petrolatum is also approved as an active ingredient in OTC skin protectant drug products as well as in ophthalmic, and anorectal OTC drug products.
The Cosmetic Ingredient Review (CIR) has deferred evaluation of this ingredient because the safety has been assessed by FDA. This deferral of review is in accordance with CIR Procedures.
European Union (EU)
In the EU, the full refining history for petrolatum must be documented showing that the substance from which it is produced is not a carcinogen, i.e., the petrolatum must be properly refined. Petrolatum, which does not meet these requirements, is listed in Annex II of the Cosmetics Directive of the European Union and must be used in cosmetics and personal care products.
Petrolatum (mineral oil jelly) is used widely in cosmetics as a moisturizer as well as in OTC drugs as a skin protectant. Its safety has been reviewed by Health Canada for these purposes. Food, drug and cosmetic petrolatum products are required to be made from highly refined petrolatum at pharmaceutical or cosmetic grade.
In Canada, if an ingredient is susceptible to impurities, the manufacturer must make sure the ingredients and products are of good quality and safe when used as directed. Manufacturers should follow Good Manufacturing Practices (GMPs) and use acceptable quality materials (for example, pharmaceutical grade). Health Canada reports that there have been no reports of unacceptable impurities (such as polycyclic aromatic hydrocarbons) in petrolatum found in Canadian products.
Myths and Facts
Misinformation circulating on the Internet about the petrolatum used in cosmetic and personal care products claims that there is a risk of contamination from polycyclic aromatic hydrocarbons (PAHs) - cancer-causing chemicals found in crude oil and its by-products. Such claims are simply not true. The petrolatum used in cosmetics and personal care products is a highly refined grade that must meet very strict safety standards, which includes limits on the content of PAHs. The purity of cosmetic grade petrolatum is also evident from its allowed uses in the U.S. as an OTC skin protectant, and in OTC ophthalmic and anorectal drugs.
Find out more about the regulation of Over-the-Counter drugs by the Food and Drug Administration
Find out more about the regulation of Food Additives by the Food and Drug Administration
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