Label: ISOPROPYL ALCOHOL 50% solution

  • NDC Code(s): 10565-003-04, 10565-003-08, 10565-003-16, 10565-003-32, view more
    10565-003-99
  • Packager: Hydrox Laboratories
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 23, 2023

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  • Drug Facts

    Active Ingredient

    Isopropyl Alcohol 50%

  • PURPOSE

    Purpose:

    First Aid Antiseptic

  • INDICATIONS & USAGE

    Usesfirst aid to help prevent the risk of infection in: minor cuts, scrapes, burns.

  • WARNINGS

    Warnings For external use only

    Flammable

    • Keep away from fire or flame, heat, spark, electrical. Flash point 72°F.
    • do not use with eletocautery procedures.

    Ask a doctor before use if you have 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 the body
    • do not use longer than 1 week unless directed by 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. If swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    <Directions clean the affected area. apply 1 to 3 times daily.

  • WARNINGS AND PRECAUTIONS

    Other information does not contain, nor is intended as a substitue for grain or ethyl alcohol. will produce serious gastric disturbances if taken internally.

  • INACTIVE INGREDIENT

    Inactive Ingredient purified water

  • Principal Display Panel

    Hydrox

    Isopropyl Rubbing Alcohol

    A cooling and refreshing and massaging compound

    50%

    First Aid Antiseptic

    TAMPER EVIDENT CAP FOR YOUR PROTECTION. IF RING-BAND IS DETACHED FROM CAP OR MISSING, DO NOT USE.

    WARNING: FLAMMABLE!

    Hydrox Laboratories

    Elgin, IL 60123

    isopropylalcohol

  • INGREDIENTS AND APPEARANCE
    ISOPROPYL ALCOHOL 50% 
    isopropyl alcohol 50% solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10565-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL50 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10565-003-04118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/11/2019
    2NDC:10565-003-08237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/11/2019
    3NDC:10565-003-16473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/11/2019
    4NDC:10565-003-32946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/11/2019
    5NDC:10565-003-993785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/11/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00306/11/2019
    Labeler - Hydrox Laboratories (025164302)
    Registrant - Hydrox Laboratories (025164302)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hydrox Laboratories025164302manufacture(10565-003) , label(10565-003) , pack(10565-003)
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