Label: ALCOHOL ANTISEPTIC 80% TOPICAL SOLUTION HAND SANITIZER NON-STERILE SOLUTION- alcohol solution

  • 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 April 14, 2020

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  • ACTIVE INGREDIENT

    Active ingredient[s]
    Alcohol 80% v/v

  • PURPOSE

    Purpose
    Antiseptic

  • INDICATIONS & USAGE

    Use[s]
    Hand Sanitizer to help reduce bacteria that potentially can cause disease.
    For use when soap and water are not available.

    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.

  • WARNINGS

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

  • DO NOT USE

  • 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 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.

  • DOSAGE & ADMINISTRATION

    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.

  • INSTRUCTIONS FOR USE

    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.

  • STORAGE AND HANDLING

    Other information
    • Store between 15–30C (59–86F)
    • Avoid freezing and excessive heat above 40C (104F)

  • INACTIVE INGREDIENT

    Inactive ingredients glycerin, hydrogen peroxide, purfied water USP

  • QUESTIONS

    Questions or comments?
    Call Toll-Free 1-800-SKIN (1-800-248-7546) Monday-Friday 9am-5:30pm ET

  • Repechage Alcohol Antiseptic 80% Topical Solution Hand Sanitizer Non-Sterile Solution

    118 mL, NDC 64521-5678-4 Repechage Alcohol Antiseptic 80% Topical Solution Hand Sanitizer Non-Sterile Solution


    59 mL, NDC 64521-5678-2

    59 mL label

    236 mL, NDC 64521-5678-8 236 mL label

    473 mL, NDC 64521-5678-1

    473 mL label

  • INGREDIENTS AND APPEARANCE
    ALCOHOL ANTISEPTIC 80% TOPICAL SOLUTION HAND SANITIZER NON-STERILE SOLUTION 
    alcohol solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64521-5678
    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)  
    WATER (UNII: 059QF0KO0R)  
    HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64521-5678-4118 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product03/31/2020
    2NDC:64521-5678-259 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product03/31/2020
    3NDC:64521-5678-8236 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product04/14/2020
    4NDC:64521-5678-1473 mL in 1 BOTTLE; Type 0: Not a Combination Product04/14/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/31/2020
    Labeler - Sarkli-Repechage, Ltd. (012583931)
    Registrant - Sarkli-Repechage, Ltd. (012583931)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sarkli-Repechage, Ltd.012583931manufacture(64521-5678)
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