The Product PDF
Allantoin has been classified by the Food and Drug Administration (FDA) Over-the-Counter (OTC) Topical Analgesic Review Panel as a Category I (safe and effective) active ingredient skin protectant when used at 2.0%. Allantoin has been widely used for decades in cosmetic and OTC topical formulations because it is so effective at only 0.5%, making it an economical anti-inflammatory additive. The most popular applications are in the prevention and treatment of dry and chapped skin and lips.
Allantoin is also used in the topical pharmaceutical market in psoriasis medications and analgesic gels. Allantoin has been used in various dental preparations such as toothpastes and oral rinses.
Allantoin produces its desirable effects by promoting healthy skin. It is postulated that Allantoin cleanses away necrotic tissue, speeding up the growth of new, healthy tissue. Since Allantoin stimulates new and healthy tissue growth, healing epithelization may take place. Allantoin also has been described as a cell proliferant, an epithelization stimulant and a chemical debrider in texts such as the United States Dispensatory, Merck Index, and British Pharmaceutical Codex. Allantoin is an amphoteric compound that is anionic under basic conditions. Allantoin is compatible with most ingredients used in personal care formulations.
- white free flowing powder
- water soluble - 1g to 199ml
- store tightly closed and away from direct heat and moisture
- 36 mos. when stored properly
- * add to room temperature, 76F, water phase, then heat to 130F to ensure solubilization
- 0.5 to 2.0%
- Hand and body creams and lotions
- Lipsticks and lip ointments
- Shaving products
- Sun and after-sun care products
- Face and baby wipes
- Baby and foot powders
- Acne products
- Anti-perspirants and deodorants
- Diaper rash creams
KEY FEATURES AND BENEFITS
Soaps, detergents, acidic or alkaline materials, mechanical means or the environment can irritate skin and lips. Allantoin helps alleviate and prevent symptoms of irritated and dry skin, and dry / chapped lips.
The U.S. Food and Drug Administration in the Tentative Monograph, 48 Federal Register 6820-33 defines Allantoin as a skin protectant. A skin protectant is a drug which protects injured or exposed skin or mucous membrane surfaces from harmful or annoying stimuli. The FDA has approved the use of 0.5% to 2.0% Allantoin for the:
Temporary protection of minor cuts, scrapes, burns and sunburns.
Prevention and temporary protection of chafed, chapped, cracked, or wind-burned skin and lips.
Relief of dryness and softening of cold sores and fever blisters.
Treatment and prevention of diaper rash and to help protect/seal out wetness. The FDA considers such explicit claims as drug claims.
When 0.5% to 2.0% Allantoin is added to cosmetic and personal care products and no claims are made related to Allantoin, the product remains a cosmetic. The most updated FDA regulations should be consulted since the above approved uses are listed in the current tentative Final Monograph and may be modified once the Final Monograph is published.
* Note: It is important to follow these guidelines as failure to do so may result in the product forming small masses (fish eyes) as it cools, which will present itself, in your formulation, as grit. This condition is irreversible but will not effect its anti-inflammatory activity. Good agitation is required to thoroughly disperse the Allantoin to achieve a suitable suspension. Addition of Allantoin at 0.5% or more or at temperatures above 50C in aqueous systems can cause solubilization and recrystallization upon cooling into larger particles which are perceptible during product use.