Label: HAND SANITIZER- ethyl alcohol cloth

  • 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 October 9, 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. Hydrogen peroxide (0.125% v/v).
    4. 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.

  • MEDICINAL INGREDIENTS

    Ethyl Alcohol, USP 80% v/v

  • RECOMMENDED USE

    Antiseptic skin cleanser

  • DURATION OF USE AND RECOMMENDED DOSE:

    • Children 2 - 11 years • Adolescents 12 - 17 years • Adults 18 years and older: Supervise children when they use this product. For occasional and personal domestic use. Rub thoroughly into hands for at least 30 seconds. Allow to dry.

  • CAUTIONS AND WARNINGS:

    Flammability warning: Keep away from open flame and sources of heat. For external use only. Keep out of reach of children. If swallowed, call a poison control centre or get medical help right away.

  • Contraindications:

    Do not use on children/infants less than 2 years of age (unless directed by a doctor/physician/ health care practitioner/ health care provider/ health care professional.

  • WHEN USING

    When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water.

  • STOP USE

    Stop use and ask/ consult a doctor/ physician/ health care practitioner/ health care provider/ health care professional if irritation develops.

  • 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

    Children 2 - 11 years • Adolescents 12 - 17 years • Adults 18 years and older: Supervise children when they use this product. For occasional and personal domestic use. Rub thoroughly into hands for at least 30 seconds. Allow to dry.

  • Other information

    • Store between 15-30C (59-86F)
    • Avoid freezing and excessive heat above 40C (104F)
  • Inactive ingredients

    glycerin, hydrogen peroxide, purified water

  • Package Label - Principal Display Panel

    270 Wipes

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    ethyl alcohol cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78806-500
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL80 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX) 1.45 mL  in 100 mL
    HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.125 mL  in 100 mL
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78806-500-40270 in 1 CANISTER08/14/2020
    15 mL in 1 PACKAGE; Type 0: Not a Combination Product
    2NDC:78806-500-50450 in 1 CANISTER08/14/2020
    25 mL in 1 PACKAGE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/30/2020
    Labeler - All Clean Natural Ltd. (203593355)
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