Label: HAND SANITIZER- ethyl alcohol gel

  • 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 June 18, 2020

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  • 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) (62%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
    Water (35.31 % v/v)
    Glycerin (2.0 % v/v)
    Carbomer (0.35 % v/v)
    PEG-40 Hydrogenated Castor Oil (0.2 % v/v)
    Chloroxylenol (0.1 % v/v)
    Sodium Hydroxide (0.04 % v/v)

    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 70% v/v. Purpose: Antiseptic

  • Purpose

    Antiseptic, Hand Sanitizer

  • Use

    Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

  • Warnings

    For external use only. Flammable. Keep away from heat or flame

  • Do not use

    in children less than 2 months of age
    on open skin wounds

  • WHEN USING

    When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • STOP USE

    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

  • 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.

  • Directions

    Place enough product on hands to cover all surfaces. Rub hands together until dry.
    Supervise children under 6 years of age when using this product to avoid swallowing.

  • Other information

    Store between 15-30C (59-86F)
    Avoid freezing and excessive heat above 40C (104F)

  • Inactive ingredients

    Water, Glycerin, Carbomer, Peg-40
    Hydrogenated Castor Oil,
    Chloroxylenol, Sodium Hydroxide.

  • Package Label

    251 mL NDC: 75951-8099-8

    Front

    Back

    Label

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75951-8099
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) 0.35 mL  in 100 mL
    WATER (UNII: 059QF0KO0R) 35.31 mL  in 100 mL
    CHLOROXYLENOL (UNII: 0F32U78V2Q) 0.1 mL  in 100 mL
    SODIUM HYDROXIDE (UNII: 55X04QC32I) 0.04 mL  in 100 mL
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F) 0.2 mL  in 100 mL
    GLYCERIN (UNII: PDC6A3C0OX) 2 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75951-8099-8251 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/30/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/30/2020
    Labeler - Olympic Mountain Products, Inc. (103355350)
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