Label: 75% ALCOHOL- alcohol liquid

  • NDC Code(s): 75532-002-01, 75532-002-02, 75532-002-03
  • Packager: Shandong Retouch Wash And Sterilize Technology Co.,ltd.
  • 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 10, 2023

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  • Active Ingredient(s)

    Alcohol 75% v/v. Purpose: First Aid Antiseptic

  • Purpose

    First Aid Antiseptic

  • Use

    first aid to help prevent the risk of infection in minor cuts, scrapes and burns

  • Warnings

    For external use only. Flammable.

    Keep away from heat, flame, spark, electrical.

  • Do not use

    if allergy to alcohol

  • When using this product

    keep out of eyes, ears, and mouth.

    do not apply over large areas of the body.

    do not use longer than 1 week unless directed by a doctor.

  • STOP USE

    Stop use and ask a doctor if condition persists or gets worse.

  • 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

    Clean the affected area

    Wash with this product on the area for 1-3 minutes

  • Other information

    Store in a cool, dry place (below 86F). Keep sealed.

    Supervises children under 6 years of age when using this product to avoid swallowing.

  • Inactive ingredients

    purified water

  • Package Label - Principal Display Panel

    500 mL NDC:75532-002-01

    PDP

    75532-002-01 1000ml

    PDP

    75532-002-03 4000ml

    PDP

  • INGREDIENTS AND APPEARANCE
    75% ALCOHOL 
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75532-002
    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:75532-002-021000 mL in 1 BOTTLE; Type 0: Not a Combination Product04/21/2020
    2NDC:75532-002-01500 mL in 1 BOTTLE; Type 0: Not a Combination Product04/21/2020
    3NDC:75532-002-034000 mL in 1 BOTTLE; Type 0: Not a Combination Product04/21/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/21/2020
    Labeler - Shandong Retouch Wash And Sterilize Technology Co.,ltd. (529300365)
    Establishment
    NameAddressID/FEIBusiness Operations
    Shandong Retouch Wash And Sterilize Technology Co.,ltd.529300365manufacture(75532-002)
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