Label: HAND SANITIZER ISOPROPYL ALCOHOL ANTISEPTIC 70% TOPICAL GEL- 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 August 31, 2020

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  • Hand Sanitizer Isopropyl Alcohol Antiseptic 70% Topical Gel

    This is a hand sanitizer manufactured according to the part333A of the OTC monograph.
    The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentag
    formulation)
    a. Isopropyl Alcohol (70%, v/v) in an aqueos solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
    b. Glycerol (1.5% v/v).
    c. Hydroxymethyl Cellulose (1.3% v/v) .
    d. Sterile distilled water or boiled cold water.

  • Active Ingredient(s)

    Isopropyl 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

    glycerin, methylcellulose, purified water USP

  • Hand Sanitizer Isopropyl Alcohol Antiseptic 70% Topical Gel

    18927000 ml label NDC 79975-004-0118927000 ml NDC: 79975-004-01

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER ISOPROPYL ALCOHOL ANTISEPTIC 70% TOPICAL GEL 
    isopropyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79975-004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    HYDROXYMETHYL CELLULOSE (UNII: 273FM27VK1) 1.3 mL  in 100 mL
    GLYCERIN (UNII: PDC6A3C0OX) 1.5 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79975-004-0118927000 mL in 1 TANK; Type 0: Not a Combination Product08/31/2020
    2NDC:79975-004-021249000 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product08/31/2020
    3NDC:79975-004-03208198 mL in 1 DRUM; Type 0: Not a Combination Product08/31/2020
    4NDC:79975-004-0418927 mL in 1 DRUM; Type 0: Not a Combination Product08/31/2020
    5NDC:79975-004-053785 mL in 1 PAIL; Type 0: Not a Combination Product08/31/2020
    6NDC:79975-004-091000 mL in 1 BOTTLE; Type 0: Not a Combination Product08/31/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/31/2020
    Labeler - Solugen Blending LLC (117590261)
    Establishment
    NameAddressID/FEIBusiness Operations
    Solugen Blending LLC117590261manufacture(79975-004)
    Establishment
    NameAddressID/FEIBusiness Operations
    Solgen Blending LLC117605218manufacture(79975-004)
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