Label: 75% ALCOHOL DISPOSABLE DISINFECTANT GEL- alcohol gel

  • Contains inactivated NDC Code(s)
    NDC Code(s):     75614-111-01, 75614-111-02, 75614-111-03, 75614-111-04, view more
    75614-111-05, 75614-111-06, 75614-111-07, 75614-111-08, 75614-111-09, 75614-111-10, 75614-111-11
  • Packager: Guangzhou Pinshang Biotechnology Development Co.,Ltd.
  • 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 May 7, 2020

If you are a consumer or patient please visit this version.

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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. Isopropyl Alcohol (75%, 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 75% v/v. Purpose: Antiseptic

  • Purpose

    Antiseptic, Hand Sanitizer

  • 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.

  • 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

    100ml NDC:75614-111-01 100ml label

    60ml NDC:75614-111-02 60ml

    236ml NDC:75614-111-03 236ml label

    250ml NDC:75614-111-04 250ml

    300ml NDC:75614-111-05 300ml

    500ml NDC:75614-111-06 500ml label

    30ml NDC:75614-111-07 30ml label

    200ml NDC:75614-111-08 200ml label

    1000ml/1L NDC:75614-111-09 1000ml label

    3800ml/3.8L NDC:75614-111-10 3.8L label

    5000ml/5L NDC:75614-111-11 5L label

  • INGREDIENTS AND APPEARANCE
    75% ALCOHOL DISPOSABLE DISINFECTANT GEL 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75614-111
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 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:75614-111-01100 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product04/29/2020
    2NDC:75614-111-0260 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product04/29/2020
    3NDC:75614-111-03236 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product04/29/2020
    4NDC:75614-111-04250 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product04/29/2020
    5NDC:75614-111-05300 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product04/29/2020
    6NDC:75614-111-06500 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product04/29/2020
    7NDC:75614-111-0730 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product04/29/2020
    8NDC:75614-111-08200 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product04/29/2020
    9NDC:75614-111-091000 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product04/29/2020
    10NDC:75614-111-103800 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product04/29/2020
    11NDC:75614-111-115000 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product04/29/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/29/2020
    Labeler - Guangzhou Pinshang Biotechnology Development Co.,Ltd. (554530020)
    Registrant - Guangzhou Pinshang Biotechnology Development Co.,Ltd. (554530020)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guangzhou Pinshang Biotechnology Development Co.,Ltd.554530020manufacture(75614-111)
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