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 July 22, 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. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, 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 (1.45% v/v).
    3. TRIETHANOLAMINE BENZOATE (0.125% v/v).
    4. Carbomer 940 0.5%
    5. Sterile distilled water or boiled cold water.

    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 70%. Purpose: Antiseptic

  • Purpose

    Antiseptic, Hand Sanitizer

  • Use

    To decrease bacteria on the skin that could cause disease, Recommended for repeated use

  • Warnings

    For external use only: hands Do not drink Flammable. Keep away from heat and flame

  • Do not use

    • in children less than 2 months of age
    • on open skin wounds
  • WHEN USING

    Keep out of eyes in case of contact with eyes, flush thoroughly with water, Avoid contact with broken skin,

    Do not inhale or ingest.

  • STOP USE

    Skin irritation develops.

  • KEEP OUT OF REACH OF CHILDREN

    If swallowed, get medical help or contact a Poison Control Center Right away.

  • Directions

    Wet hands thoroughly with product and allow to dry without wiping. For children under 6, use only under adult supervision. Not recommended for infants.

  • Other information

    Do not store above105oF, may discolor some fabrics, Harmful to wood finishes and plastics.

  • Inactive ingredients

    Purified Water, Glycerin, Triethanolamine, Carbomer.

  • Package Label - Principal Display Panel

    1.000 mL1000 mL NDC: 79219-001-02

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79219-001
    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) 1.45 mL  in 100 mL
    TRIETHANOLAMINE BENZOATE (UNII: M3EN4GC19W) 0.125 mL  in 100 mL
    WATER (UNII: 059QF0KO0R)  
    CARBOMER 940 (UNII: 4Q93RCW27E) 0.5 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79219-001-021000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/20/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/30/2020
    Labeler - Tu Negocio En Minutos SA de CV (951578971)
    Registrant - Tu Negocio En Minutos SA de CV (951578971)
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