Label: AMERICAN BEAUTY ADVANCED HAND SANITIZER- alcohol gel

  • NDC Code(s): 76907-401-01
  • Packager: American Beauty Manufacturing Inc
  • Category: HUMAN OTC DRUG LABEL

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.

Drug Label Information

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)

    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

    • Place enough product in your palm to thoroughly cover your hands
    • Rub hands together until dry
    • No rinsing or towels required
  • Inactive ingredients

    water, glycerin, hydroxypropylcellulos, isopropyl myristate, tocopheryl acetate

  • KEEP OUT OF REACH OF CHILDREN

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

  • QUESTIONS

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

    contact@americanbeautymfg.com

  • OTHER SAFETY INFORMATION

    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

  • INGREDIENTS AND APPEARANCE
    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)