Label: LIFEWISE HAND SANITIZER- alcohol spray

  • Category: HUMAN OTC DRUG LABEL

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 29, 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.

  • Active Ingredient(s)

    Ethyl Alcohol 80% v/v. Purpose: Antiseptic

  • Purpose

    Antiseptic, Hand Sanitizer

  • Use

    To reduce germs and bacteria when soap and water are not available.

  • Warnings

    For external use only. Flammable. Keep away from fire or flame.

  • Do not use

    Do not use on children less than 2 months of age or on open skin wounds.

  • WHEN USING

    Keep away from eyes, ears, and mouth. In case of contact with eyes, rinse thoroughly with water.

  • STOP USE

    If irritation or rash occurs, stop use and consult a doctor. These may be signs of a serious condition.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children and pets. If swallowed, get medical help or contact a Poison Control Center immediately.

  • Directions

    Apply generously. Rub all over both hands until dry.

  • Other information

    Store between 59-86°F (15-30°C). May discolor fabrics and surfaces.

  • Inactive ingredients

    glycerin, hydrogen peroxide, purified water USP

  • Package Label - Principal Display Panel

    NDC: 80019-520-01/02/03

    Catalog No. 6405201/2/3

    Label Front

  • INGREDIENTS AND APPEARANCE
    LIFEWISE HAND SANITIZER 
    alcohol spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80019-520
    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:80019-520-02236 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product08/31/2020
    2NDC:80019-520-0151 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product08/31/2020
    3NDC:80019-520-03473 mL in 1 BOTTLE, SPRAY; 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 - General Wireless Operations Inc. (079852110)
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