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
  • 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 November 8, 2022

If you are a consumer or patient please visit this version.

  • Drug Facts

    Active Ingredient

    Isopropyl Alcohol 50%

  • PURPOSE

    Purpose:

    First Aid Antiseptic

  • INDICATIONS & USAGE

    Uses first 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

    isopropylalcoholHydrox

    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 not finalpart333A06/11/2019
    Labeler - Hydrox Laboratories (025164302)
    Registrant - Hydrox Laboratories (025164302)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hydrox Laboratories025164302manufacture(10565-003) , label(10565-003) , pack(10565-003)