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ALLANTOIN - artificial in cosmetics but natural in snail secretions and thus in Elicina Cream.
Properties: Promotes wound healing, speeds up cell regeneration, and has a keratolytic (skin-softening) effect. Allantoin has been termed a cell proliferant, an epithelization stimulant, and a chemical debrider in texts such as the 'United States Dispensatory', 'Merck Index' and 'British Pharmaceutical Codex'. It is said to clean away necrotic tissue, hastening the growth of new healthy tissue. Since Allantoin stimulates new and healthy tissue growth, healing epithelization may take place. The FDA OTC Panel has not recognized Allantoin as a wound healing agent, only as a skin protectant.
Allantoin has been also termed a counter irritant that helps alleviate the untoward skin-irritation effects of certain cosmetic ingredients such as soap and detergent surfactants, oils and acidic or alkaline materials.
Allantoin produces its desirable effects by promoting and speeding up the healthy, natural processes of the body. It helps the skin to help itself.
Description
Allantoin is a white, odorless, crystalline powder (when isolated).
Chemical name: Glyoxyl-Diureide
Inci adopted name: Allantoin
Cas registry no: 97-59-6
FDA Classification: Category I (Safe and Effective) OTC Tentative Final
Monograph on Skin Protectant Drugs
Molecular formula: C4H6N4O3
Molecular weight: 158.12
APPLICATIONS
Allantoin has long been known to enhance the efficacy and desirability of
cosmetic creams and lotions by its action as a skin protectant.
Allantoin has also been incorporated into shampoos, lipsticks, shaving creams, suntan products, bath foams, hair gels, baby powders and various aerosol preparations. It has also been used in topical pharmaceutical markets. Most recently, Allantoin has been used in various dental preparations such as toothpaste and mouthwash.
TOXICOLOGICAL DATA
The U.S. Food and Drug Administration (FDA) has classified Allantoin as a Category I (safe and effective) active ingredient skin protectant.
The FDA's Tentative Final Monograph on skin protectant drug products for Over-The-Counter (OTC) human use was published in the Federal Register (Volume 48, No. 32, pp. 6820-33 and Volume 55, No. 11, pp. 25240-81). Based on the wide use and clinical acceptance of Allantoin. As well as published reports in the literature, the FDA has approved the following statements for non-prescription drug products containing Allantoin at 0.5% to 2.0%.
For the temporary protection of minor cuts, scrapes, burns and sunburn. Helps prevent and temporarily protects chafed, chapped, cracked, or wind-burned skin and lips. Relieves dryness and softens cold sores and fever blisters. Helps treat and prevent nappy rash. Protects chafed skin/minor skin irritation due to/associated with nappy rash and helps protect from/seal out wetness.
Allantoin is considered to be non-toxic, non-irritating and non-allergenic by the Schwartz patch test on 200 individuals, as published in the Federal Register (Volume 43, No. 151, pp. 34632-34). Clinical and marketing experience has confirmed that Allantoin is safe and effective in the dosage range recommended (0.5 to 2.0%) as a skin protectant.
IMPORTANT NOTE
The U.S. Food and Drug Administration acknowledges that Allantoin at 0.5 to 2.0% concentration can be used for the prevention and treatment of chafed, chapped, cracked, sunburned or wind burned skin or lips, cold sores, fever blisters and nappy rash, but considers such explicit claims as drug claims.
When Allantoin is added to a personal care product and no claims are made the product remains a cosmetic.
The natural secretions of the snail Helix Aspersa Müller contain Allantoin combined with natural antibiotics, glycolic acid, collagen, elastin, and other proteins and vitamins in a natural bio-compatible form.
ELICINA® Cream is 80% secretions of the snail Helix Aspersa Müller plus safe excipients and contains the following ingredients in the proportions indicated: allantoin (1,2%), glycolic acid (1,6%), collagen (0,04%) and
elastin (approx. 1/12 of the contents of collagen, which is the same collagen/elastin ratio found in the human skin).
