Label: AMERICAN BEAUTY ADVANCED HAND SANITIZER- alcohol gel
- NDC Code(s): 76907-401-01
- Packager: American Beauty Manufacturing Inc
- 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 December 28, 2020
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SPL UNCLASSIFIED SECTION
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)
- Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (65%, 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).
- Hydroxypropyl Cellulose (1.00% w/w).
- Aplha-Tocopherol Acetate (0.05% w/w).
- Isopropyl Myristate (0.50% 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.
- Active Ingredient(s)
Flammable. Keep away from fire or flame.
For external use only
When using this product do not use in or near the eyes.
In case of contact with eyes, flush thoroughly with water.
Avoid contact with broken skin.
Stop use and ask a doctor if irritation or redness develop.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
- Inactive ingredients
- KEEP OUT OF REACH OF CHILDREN
- OTHER SAFETY INFORMATION
- Package Label - Principal Display Panel
INGREDIENTS AND APPEARANCE
AMERICAN BEAUTY ADVANCED HAND SANITIZER
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76907-401 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 2461 mL in 3785 mL Inactive Ingredients Ingredient Name Strength ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) 19 mL in 3785 mL GLYCERIN (UNII: PDC6A3C0OX) 55 mL in 3785 mL ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) 2 mL in 3785 mL WATER (UNII: 059QF0KO0R) 1267 mL in 3785 mL HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED (UNII: 2165RE0K14) 34 g in 3785 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76907-401-01 3785 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product 11/02/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 11/02/2020 Labeler - American Beauty Manufacturing Inc (785139648) Establishment Name Address ID/FEI Business Operations Enter Establishment Name 785139648 manufacture(76907-401)