Label: 80% ALCOHOL HAND SANITIZER- alcohol solution

  • NDC Code(s): 73956-301-28, 73956-301-64, 73956-401-08
  • Packager: Phoenix Products Company
  • 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 1, 2020

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  • SPL UNCLASSIFIED SECTION

    This is a hand rub manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Rub Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

    The hand rub 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)

    Alcohol 80% v/v. Purpose: Antiseptic

  • Purpose

    Antiseptic, Hand Rub

  • Use

    Health care personnel hand rub to help reduce bacteria that potentially can cause disease.

  • 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

    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

    glycerin, hydrogen peroxide, purified water USP

  • Package Label - Principal Display Panel

    KMS

    * Effective at eliminating 99.9% of many

    common harmful germs and bacteria.

    ** Meets the FDA healthcare personnel

    antiseptic hand rub criteria

    Made in USA

    Empty &

    Discard Pump

    PLASTIC BOTTLE

    how2recycle.info

    Distributed by

    KMS, Inc.

    811 E Waterman St.

    Wichita, KS 67208

    SDA-NE-1013

    0 79902 07899 8

    ALCOHOL ANTISEPTIC 80 % TOPICAL SOLUTION

    HAND
    SANITIZER

    KILLS 99.9% OF GERMS*

    FORMULATED FOR HEALTHCARE**

    GENTLE ENOUGH FOR EVERYDAY USE

    NON-STERILE LIQUID SOLUTION

    WARNING FOR EXTERNAL USE ONLY

    FLAMMABLE. KEEP AWAY FROM HEAT OR FLAMES

    64 FL OZ (1.89 L)

    73956-301-64 Bottle Image

  • Package Label - Principal Display Panel

    [Kinnos 8 oz]

    kinnos

    HAND SANITIZER

    8 oz (237mL)

    We started this company to
    protect healthcare workers,
    patients, and friends and
    family from infections. At
    Kinnos, our goal is to
    empower people to protect
    themselves and others, and
    to provide society with
    peace of mind.


    Join us at www.kinnos.us


    Alcohol Antiseptic
    (80%)
    Topical solution
    Non-sterile

    Manufactured by Kinnos Inc.

    760 Parkside Avenue, Suite 219

    Brooklyn, NY 11226

    team@kinnos.us | (978) 314-3127

    LB0009 Rev A

    8 60949 00049 9

    73956-401-08 Bottle Image

  • INGREDIENTS AND APPEARANCE
    80% ALCOHOL HAND SANITIZER 
    alcohol solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73956-301
    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) 18.42 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73956-301-641893 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/2020
    2NDC:73956-301-283785 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/01/2020
    80% ALCOHOL HAND SANITIZER 
    alcohol solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73956-401
    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) 18.42 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73956-401-08237 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/01/2020
    Labeler - Phoenix Products Company (101332237)
    Establishment
    NameAddressID/FEIBusiness Operations
    Phoenix Products Company101332237manufacture(73956-301, 73956-401)
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