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
  • 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 September 14, 2021

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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 warning Keep 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 if irritation 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 CANISTER09/14/2021
    15 mL in 1 PACKET; Type 0: Not a Combination Product
    2NDC:50021-017-02180 in 1 CANISTER09/14/2021
    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 not finalpart333A09/14/2021
    Labeler - Empack Spraytech Inc. (252047519)
    Registrant - Empack Spraytech Inc. (252047519)
    Establishment
    NameAddressID/FEIBusiness Operations
    Empack Spraytech Inc.252047519manufacture(50021-017)
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