Label: CLEACE ALCOHOL DISINFECTANT- alcohol liquid

  • NDC Code(s): 74621-009-01, 74621-009-02
  • Packager: AOGRAND INTERNATIONAL TRADE CORPORATION
  • 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 February 11, 2023

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  • Active Ingredient

    Alcohol 75% v/v. Antiseptic

  • Purpose

    Antiseptic

  • Uses

    helps prevent the risk of infection in

    • minor cuts
    • scrapes
    • burns
    • surface disinfection of household
    • table
    • chair
    • sofa
    • clothes
    • shoes
  • Warnings

    For external use only.

    Flammable.

    Keep away from fire or flame, heat, spark, electrical

  • Ask a doctor before use

    for deep or puncture wounds, animal bites or serious burns

  • When using this product

    • do not get into eyes.
    • do not apply over large areas of body
    • do not use longer than 1 week unless directed bu a doctor
  • Stop use and ask a doctor

    if condition persists or gets worse.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. Children must be supervised in use of this product.

  • Caution

    Fumes can be acutely irritating to skin, eyes and the respiratory system. Do not apply to irritated skin or if excessive irritation develops. Avoid getting into the eyes or on mucous membranes. Avoid inhaling this product.

  • Directions

    • clean affected area
    • apply small amount of this product on the area 1 to 3 times daily
    • may be covered with a sterile bandage
    • if bandaged, let dry first
  • Inactive ingredients

    water.

  • Other information

    Store at room temperature and avoid direct sunlight

    will produce serious gastric disturbances if taken internally

    for surface contact that may cause discoloration, test first in areas that are not obvious

  • Package Label - Principal Display Panel

    74621-009-01 280mL

    PDP

    74621-009-02 5000 mL

    PDP

  • INGREDIENTS AND APPEARANCE
    CLEACE ALCOHOL DISINFECTANT 
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74621-009
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74621-009-01280 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/31/2020
    2NDC:74621-009-025000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/31/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/31/2020
    Labeler - AOGRAND INTERNATIONAL TRADE CORPORATION (421353092)
    Establishment
    NameAddressID/FEIBusiness Operations
    AOGRAND INTERNATIONAL TRADE CORPORATION421353092manufacture(74621-009)
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