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 June 16, 2020

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  • SPL UNCLASSIFIED SECTION

    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.

    The hand sanitizer is manufactured using only the following ingredients in the preparation of the product:

    Alcohol (ethanol) 75%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
    Sterile distilled water or boiled cold water.
    Hydrogen Peroxide
    Glycerin
    Isopropyl Misrate
    Carbomer and/or Crosspolymers
    Aloe Arborescens Leaf
    Tocopheryl Acetate
    Fragrance

    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 75% 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
    • In eyes. In case of contact, rinse eyes thoroughly with water
  • 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, Hydrogen Peroxide, Glycerin, Carbomer and/or Crosspolymers, Isopropyl Myristate, Aloe Arborescens Leaf, Tocopheryl Acetate, Fragrance.

  • Package Label - Principal Display Panel

    59 mL NDC: 74988-732-20 2 oz
    118 mL NDC: 74988-732-40 4 oz
    236 mL NDC: 74988-732-80 8 oz
    473 mL NDC: 74988-732-16 16 oz
    3.79 L NDC: 74988-732-37 1 gal
    208 L NDC: 74988-732-55 drum
    1041 L NDC: 74988-732-41 tote
    25741 L NDC: 74988-732-74 tanker

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74988-732
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
    WATER (UNII: 059QF0KO0R)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    ALOE ARBORESCENS LEAF (UNII: 09TD8L5SQV)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74988-732-2059 mL in 1 BOTTLE; Type 0: Not a Combination Product06/15/2020
    2NDC:74988-732-40118 mL in 1 BOTTLE; Type 0: Not a Combination Product06/15/2020
    3NDC:74988-732-80236 mL in 1 BOTTLE; Type 0: Not a Combination Product06/15/2020
    4NDC:74988-732-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product06/15/2020
    5NDC:74988-732-373790 mL in 1 JUG; Type 0: Not a Combination Product06/15/2020
    6NDC:74988-732-55208000 mL in 1 DRUM; Type 0: Not a Combination Product06/15/2020
    7NDC:74988-732-411041000 mL in 1 TANK; Type 0: Not a Combination Product06/15/2020
    8NDC:74988-732-7425741000 mL in 1 CONTAINER; Type 0: Not a Combination Product06/15/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/15/2020
    Labeler - SanitizeNow Inc. (117475870)
    Establishment
    NameAddressID/FEIBusiness Operations
    SanitizeNow Inc.117475870manufacture(74988-732)
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