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Allantoin Glycolic Acid Glycerol Monosterate Tributyl Citrate

The U.S. Food and Drug Administration (FDA) has classified Allantoin as a Category I (safe and effective) active ingredient skin protestant.

The FDA's Tentative Final Monograph on skin protestant 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%.

1. For the temporary protection of minor cuts, scrapes, burns and sunburn.
2. Helps prevent and temporarily protects chafed, chapped, cracked, or wind-burned skin and lips.
3. Relieves dryness and softens cold sores and fever blisters.
4. Helps treat and prevent diaper rash. Protects chafed skin/minor skin irritation due to/associated with diaper
rash and helps protect from/seal out wetness

SPECIFICATIONS