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 October 15, 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)

    Alcohol 80% v/v. Purpose: Antiseptic

  • Purpose

    Antimicrobial

  • Use

    Dry Hand Sanitizer helps prevent the development of bacteria on the skin.

    It moisturizes and softens the hand skin with the sweet fragrance.

  • Warnings

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

  • Do not use

    • for children under 36 months.
  • WHEN USING


    Stop use and ask a doctor if irritation and redness develop and persist for more than 72 hours.


    For children: need to be supervised by adults when using it.

  • STOP USE

    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

  • 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 in dry and cool place
  • Inactive ingredients

    glycerin, hydrogen peroxide, purified water USP

  • KEEP OUT OF REACH OF CHILDREN

    Keep our of reach of children

  • Package Label - Principal Display Panel

    100 mL NDC: 90098-100-01

    90098-100-01

    250 mL NDC: 90098-100-02

    90098-100-02

    500 mL NDC: 90098-100-03

    90098-100-03

    1000 mL NDC: 90098-100-04

    90098-100-04

    2000 mL NDC: 90098-100-05

    90098-100-05

    10000 mL NDC: 90098-100-06

    90098-100-06

    20000 mL NDC: 90098-100-07

    90098-100-07

    59 mL NDC: 90098-100-08

    90098-100-08

    1 Gallon NDC: 90098-100-09

    90098-100-09

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:90098-100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL72 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R) 22 mL  in 100 mL
    MINT (UNII: FV98Z8GITP) 6 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:90098-100-01100 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    2NDC:90098-100-02250 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    3NDC:90098-100-03500 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    4NDC:90098-100-041000 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    5NDC:90098-100-052000 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    6NDC:90098-100-0610000 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    7NDC:90098-100-0720000 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    8NDC:90098-100-0859 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    9NDC:90098-100-0920000 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/30/2020
    Labeler - TRANG LY PHARMA TRADE COMPANY LIMITED (555252970)
    Registrant - TRANG LY PHARMA TRADE COMPANY LIMITED (555252970)
    Establishment
    NameAddressID/FEIBusiness Operations
    TRANG LY PHARMA TRADE COMPANY LIMITED555252970manufacture(90098-100)
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