AMERICAN BEAUTY ADVANCED HAND SANITIZER- alcohol gel 
American Beauty Manufacturing Inc

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.

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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)

  1. 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.
  2. Glycerol (1.45% v/v).
  3. Hydroxypropyl Cellulose (1.00% w/w).
  4. Aplha-Tocopherol Acetate (0.05% w/w).
  5. Isopropyl Myristate (0.50% v/v)
  6. 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)

Alcohol 65% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease.

Recommended for repeated use

Warnings

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.

Directions

Inactive ingredients

water, glycerin, hydroxypropylcellulos, isopropyl myristate, tocopheryl acetate

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Call 918-516-8340 Monday to Friday 8:00am to 5:00pm CST

contact@americanbeautymfg.com

Do not store above 110*F (43*C)

May discolor certain fabrics or surfaces

Package Label - Principal Display Panel

3.78L NDC: 76907-401-01

3.78L Label

AMERICAN BEAUTY ADVANCED HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76907-401
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL2461 mL  in 3785 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76907-401-013785 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product11/02/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A11/02/2020
Labeler - American Beauty Manufacturing Inc (785139648)
Establishment
NameAddressID/FEIBusiness Operations
Enter Establishment Name785139648manufacture(76907-401)

Revised: 12/2020
Document Id: b788dd71-173d-a69a-e053-2995a90a85ba
Set id: b788cfa9-5121-6fd1-e053-2a95a90a42ac
Version: 1
Effective Time: 20201228
 
American Beauty Manufacturing Inc