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 5, 2020

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  • SPL UNCLASSIFIED SECTION

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

    1. Alcohol (ethanol) (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. Glycerol (0.2% v/v).
    3. Trolamine (0.15% v/v).
      d. Carbomer (0.3 % )
      e. Sterile distilled water or boiled cold water.
  • Active Ingredient(s)

    Alcohol 70% v/v. Purpose: Antiseptic

  • 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 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.

  • Inactive ingredients

    glycerin, trolamine, carbomer, streriled or distilled water

  • Other information

    • Store between 15-30C (59-86F)
    • Avoid freezing and excessive heat above 40C (104F)
  • 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.
  • Package Label - Principal Display Panel

    Hand Sanitizer 1 Gallon 1 gallon NDC: 78361-002-04



    1000 ml label

    1000 ml NDC 78361-002-06

    500 ml label500 ml NDC 78361-002-07


    250 ml label 250 ml NDC 78361-002-08


    60 ml label60 ml NDC 78361-002-09

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78361-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX) 0.3 mL  in 100 mL
    WATER (UNII: 059QF0KO0R)  
    TROLAMINE (UNII: 9O3K93S3TK) 0.1 mL  in 100 mL
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) 0.4 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78361-002-053780 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    2NDC:78361-002-061000 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    3NDC:78361-002-07500 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    4NDC:78361-002-08250 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    5NDC:78361-002-0960 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/30/2020
    Labeler - Diquisa, S.A. de C.V (815736509)
    Establishment
    NameAddressID/FEIBusiness Operations
    Diquisa, S.A. de C.V.815736509manufacture(78361-002)
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