Label: HAND SANITIZER GEL WITH FRAGRANCE- isopropyl 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 September 23, 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. Isopropyl Alcohol (75%, 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. Triethanolamine.
    5. Propylene glycol.
    6. Acrylic copolymer or carbomer.
    7. Fragrance.
    8. Sterile distilled water or boiled cold water.

    The formulation meets the required efficacy for the protection of human health from germs and viruses when used in the absence of water and soap.

  • Active Ingredient(s)

    Isopropyl 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
  • 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

    glycerin, hydrogen peroxide, triethanolamine, propylene glycol, acrylic copolymer and/or carbomer, fragrance, purified water USP

  • Package Label - Principal Display Panel

    118 mL NDC:74664-007-01 74664-007-01236 mL NDC: 74664-007-02 74664-007-02473 mL NDC: 74664-007-03 74664-007-0318900 mL NDC: 74664-007-04 74664-007-0420800 mL NDC: 74664-007-05 74664-007-051041000 mL NDC: 74664-007-06 74664-007-0612491000 mL NDC: 74664-007-07 74664-007-0724605000 mL NDC: 74664-007-08 74664-007-08

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER GEL WITH FRAGRANCE 
    isopropyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74664-007
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL75 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ACRYLIC ACID/SODIUM ACRYLATE COPOLYMER (1:1; 600 MPA.S AT 0.2%) (UNII: M4PPW69Y4H)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALOE (UNII: V5VD430YW9)  
    GLYCERIN (UNII: PDC6A3C0OX) 1.45 mL  in 100 mL
    HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.367 mL  in 100 mL
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74664-007-01118 mL in 1 BOTTLE; Type 0: Not a Combination Product09/18/2020
    2NDC:74664-007-02236 mL in 1 BOTTLE; Type 0: Not a Combination Product09/18/2020
    3NDC:74664-007-0318900 mL in 1 PAIL; Type 0: Not a Combination Product09/18/2020
    4NDC:74664-007-051041000 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product09/18/2020
    5NDC:74664-007-061249000 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product09/18/2020
    6NDC:74664-007-0724605000 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product09/18/2020
    7NDC:74664-007-0420800 mL in 1 DRUM; Type 0: Not a Combination Product09/18/2020
    8NDC:74664-007-08473 mL in 1 BOTTLE; Type 0: Not a Combination Product09/18/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A09/18/2020
    Labeler - Tri-Chem Industries (798244414)
    Registrant - Tri-Chem Industries (798244414)
    Establishment
    NameAddressID/FEIBusiness Operations
    Tri-Chem Industries798244414manufacture(74664-007) , label(74664-007) , pack(74664-007) , repack(74664-007) , relabel(74664-007)
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