Label: SANITIZER WIPES 70% ETHYL ALCOHOL- alcohol cloth

  • NDC Code(s): 50021-017-01, 50021-017-02
  • Packager: Empack Spraytech Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 12, 2024

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  • SPL UNCLASSIFIED SECTION

    This is a hand sanitizer wipes with Alcohol 70% v/v.

  • Active Ingredient

    Ethyl Alcohol 70% (v/v)

  • Purpose

    Antiseptic

  • Uses

    • 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.

    Flammability warningKeep away from open flame and sources of heat.

  • DO NOT USE

    Do not use• on children less than 2 months of age • on open skin wounds.

  • WHEN USING

    When using this product, avoid contact with eyes. If contact occurs, rinse thoroughly with water.

  • STOP USE

    Stop use and ask a doctor ifirritation develops.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.Topical. If swallowed, call a poison control centre or get medical help right away.

  • Directions

    • Adults and children over 2 years: • For occasional and personal domestic use • Supervise children under 6 years of age when using this product to avoid swallowing • Rub thoroughly into hands for at least 30 seconds. Allow to dry.

  • Other information

    • Store at room temperature 15-30°C (59-86°F)
    • Avoid freezing and extensive heat above 40°C (104°F)

  • Inactive ingredients

    Water, Fragrance

  • Package Label - Principal Display Panel

    LabelLabel

  • INGREDIENTS AND APPEARANCE
    SANITIZER WIPES 70% ETHYL ALCOHOL 
    alcohol cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50021-017
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    FRAGRANCE LEMON ORC2001060 (UNII: K1725A7G95)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50021-017-01100 in 1 CANISTER09/14/202112/12/2024
    15 mL in 1 PACKET; Type 0: Not a Combination Product
    2NDC:50021-017-02180 in 1 CANISTER09/14/202112/12/2024
    25 mL in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00309/14/202112/12/2024
    Labeler - Empack Spraytech Inc. (252047519)
    Registrant - Empack Spraytech Inc. (252047519)
    Establishment
    NameAddressID/FEIBusiness Operations
    Empack Spraytech Inc.252047519manufacture(50021-017)
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