Label: HAND SANITIZER- alcohol gel

  • 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.

Drug Label Information

Updated July 28, 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:

    1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, 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. Hydrogen peroxide (0.125% v/v).
    4. 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)

    Ethyl Alcohol

  • Purpose

    Antiseptic

  • 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 ingest or inhale.

  • 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

    Stop use and ask a doctor if irritation or rash occurs. Condition persists for more than 72 hours.

  • 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

    Fragrance (Parfum), Glycerin, Isopropy Myristate, Polyethylene Glycol/Acrylates Copolymer, Tocopheryl Acetate, Water

  • Package Label - Principal Display Panel

    237 mL NDC: 75594-021-01 Fresh 8oz Bottle

    355mL NDC: 75594-021-07 Fresh 12oz Bottle

    473 mL NDC: 75594-021-02 Fresh 16oz Bottle

    946 mL NDC: 75594-021-03 Fresh 32oz Bottle

    1.89 L NDC: 75594-021-04 Fresh 64oz Bottle

    3.78 L NDC: 75594-021-05 Fresh 1 Gal Bottle

    208 L NDC: 75594-021-06 HHCO Drum Label

    1249L NDC: 75594-021-08 HHCO Tote

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75594-021(NDC:77034-002)
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.7 L  in 1 L
    Inactive Ingredients
    Ingredient NameStrength
    AMMONIUM POLYACRYLOYLDIMETHYL TAURATE (55000 MPA.S) (UNII: F01RIY4371)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    METHYLCELLULOSE, UNSPECIFIED (UNII: Z944H5SN0H)  
    HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75594-021-010.237 L in 1 BOTTLE, PUMP; Type 0: Not a Combination Product07/28/2020
    2NDC:75594-021-020.473 L in 1 BOTTLE, PUMP; Type 0: Not a Combination Product07/28/2020
    3NDC:75594-021-030.946 L in 1 BOTTLE, PUMP; Type 0: Not a Combination Product07/28/2020
    4NDC:75594-021-041.89 L in 1 BOTTLE, PUMP; Type 0: Not a Combination Product07/28/2020
    5NDC:75594-021-053.78 L in 1 BOTTLE, PUMP; Type 0: Not a Combination Product07/28/2020
    6NDC:75594-021-070.354 L in 1 BOTTLE, PUMP; Type 0: Not a Combination Product07/28/2020
    7NDC:75594-021-06208 L in 1 DRUM; Type 0: Not a Combination Product07/28/2020
    8NDC:75594-021-081249 L in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product07/28/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E07/28/2020
    Labeler - Commercial Beverage Concepts, LLC (080925174)
    Establishment
    NameAddressID/FEIBusiness Operations
    Commercial Beverage Concepts, LLC080925174label(75594-021) , pack(75594-021) , relabel(75594-021) , repack(75594-021)
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