Label: HAND SANITIZER- alcohol cream

  • 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 January 13, 2021

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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

    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

  • URIGEL 60ML 80% ALCOHOL CREAM GEL

    Urigel 60ML CREAM Gel60 mL NDC: 76554-010-02

  • URIGEL 250ML 80% ALCOHOL CREAM GEL

    Urigel 250ML CREAM Gel250ML NDC: 76554-010-03

  • URIGEL 500ML 80% ALCOHOL CREAM GEL

    Urigel 500ML CREAM Gel500ML NDC: 76554-010-04

  • URIGEL 1000ML/1LTR 80% ALCOHOL CREAM GEL

    Urigel 1000ML CREAM Gel1000ML/1LTR NDC: 76554-010-05

  • URIGEL 3750ML/1GAL 80% ALCOHOL CREAM GEL

    Urigel 3.75ML CREAM Gel3750ML/1GAL NDC: 76554-010-10

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    alcohol cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76554-010
    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
    1,4-BUTANEDIOL MONOSTEARATE (UNII: OY671H06VI)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    GLYCERIN (UNII: PDC6A3C0OX) 1.45 mL  in 100 mL
    HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.125 mL  in 100 mL
    WATER (UNII: 059QF0KO0R)  
    OLEIC ACID OZONIDE (UNII: RQY857DOCC)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76554-010-0260 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    2NDC:76554-010-03250 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    3NDC:76554-010-04500 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    4NDC:76554-010-051000 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    5NDC:76554-010-103750 mL in 1 BOTTLE, PUMP; 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 - ANTISEPTICOS DE MEXICO SA DE CV (951576637)
    Registrant - ANTISEPTICOS DE MEXICO SA DE CV (951576637)
    Establishment
    NameAddressID/FEIBusiness Operations
    ANTISEPTICOS DE MEXICO SA DE CV951576637manufacture(76554-010)
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