Label: HAND SANITIZER- 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 23, 2020

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  • SPL UNCLASSIFIED SECTION

    This is a hand sanitizer manufactured using only the following United States Pharmacopoeia (USP) grade ingredients:

    1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (70%, 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 (.5% v/v).
    3. Carbopol (0.5% v/v).
    4. Triethanolamine (0.4% v/v)
    5. Sterile distilled water or boiled cold water.

  • Active Ingredient(s)

    Ethyl Alcohol 70% v/v. Purpose: Antiseptic

  • Purpose

    Antiseptic, Hand Sanitizer

  • Use

    Antiseptic Hand Sanitizer to reduce germs on skin. For use when soap and water are not available.

  • Warnings

    For external use only. Flammable. Keep away from open flame and sources of heat.

  • 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, rash or redness 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, rash or redness 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

    Apply a small amount of product into hands and rub between both sides of hands until dry. Supervise children under 6 years of age when using this product to avoid swallowing.

  • Other information

    • Store below 110F (43C)
    • Avoid freezing. May discolor certain fabrics/surfaces.
  • Inactive ingredients

    Water, glycerin, carbopol, Triethanolamine.

  • Package Label - Principal Display Panel

    976 mL NDC: 75432-003-01

    1lt kepter

    3786 mL NDC: 75432-003-02

    1 gal kepter

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75432-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL  in 100 mL
    CARBOMER 940 (UNII: 4Q93RCW27E) 0.5 mL  in 100 mL
    WATER (UNII: 059QF0KO0R) 28 mL  in 100 mL
    TROLAMINE (UNII: 9O3K93S3TK) 0.4 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75432-003-01976 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    2NDC:75432-003-023786 mL in 1 BOTTLE; 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 - Medek, LLC (055524072)
    Establishment
    NameAddressID/FEIBusiness Operations
    Medek, LLC055524072manufacture(75432-003)
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