Label: HAND GEL 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 23, 2020

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  • SPL UNCLASSIFIED SECTION

    This is an isopropyl alcohol based hand sanitizer manufactured following the CDC recomendation of using an alcohol concentration of more than 60 % v/v alcohol when soap and water is not available.

    It is manufactured by gelling a 70 % isopropyl alcohol solution with the minimum of an acrylate polymer to create a clear gel that is easy to apply and does not evaporate as readiliy as the liquid versions to provide sufficient dwell time to be effective.

    The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product::

    1. Alcohol (isopropyl alcohol) (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. Glycerin (1.00 % v/v)..
    3. Polypropylene Glycol (1.2 % v/v)..
    4. Acrylate Polymer (0.3% v/v).
    5. Sterile distilled water or boiled cold water.

    No other materials are used.

  • 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

    Water, Polypropylene Glycol, glycerin, Acrylate polymer.

  • Package Label - Principal Display Panel

    3785 ml NDC 78851-444-05

    3785 ml label946 ml NDC 78851-444-04

    946 ml label240 ml NDC 78851-444-03

    240 ml label120 ml MDC 78851-444-02

    120 ml label105 ml NDC 78851-444-01 back 105 ml label back105 ml label front105 105 ml NDC 78851-444-01 front

  • INGREDIENTS AND APPEARANCE
    HAND GEL SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78851-444
    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)  
    POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621) 1.2 mL  in 100 mL
    ALLYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (LOW ALLYL METHACRYLATE) (UNII: PI80E777XB) 0.3 mL  in 100 mL
    GLYCERIN (UNII: PDC6A3C0OX) 1 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78851-444-01105 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/23/2020
    2NDC:78851-444-02120 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/23/2020
    3NDC:78851-444-03240 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/23/2020
    4NDC:78851-444-04946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/23/2020
    5NDC:78851-444-053785 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/23/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/23/2020
    Labeler - Allied Pressroom Products (069895618)
    Registrant - Allied Pressroom Products (069895618)
    Establishment
    NameAddressID/FEIBusiness Operations
    Allied Pressroom Products069895618manufacture(78851-444)
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