Label: 100ML COCONUT HAND PURIFYING- alcohol gel
- NDC Code(s): 74819-0104-3
- Packager: LABORATOIRES BEA
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Updated June 27, 2022
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- Active Ingredient(s)
SPL UNCLASSIFIED SECTION
This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.
The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:
- Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
- Glycerol (1.45% v/v).
- Hydrogen peroxide (0.125% v/v).
- Sterile distilled water or boiled cold water.
The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.
- Do not use
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- Other information
- Inactive ingredients
- Package Label - Principal Display Panel
INGREDIENTS AND APPEARANCE
100ML COCONUT HAND PURIFYING
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:74819-0104 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 70 mL in 100 mL Inactive Ingredients Ingredient Name Strength TROLAMINE (UNII: 9O3K93S3TK) 0.15 mL in 100 mL ALOE (UNII: V5VD430YW9) 0.0005 mL in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 2 mL in 100 mL CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) 0.55 mL in 100 mL WATER (UNII: 059QF0KO0R) 25.3885 mL in 100 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:74819-0104-3 100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 02/02/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 02/02/2021 Labeler - LABORATOIRES BEA (772471215)