Label: ISOPROPYL RUBBING ALCOHOL 50%- isopropyl alcohol liquid

  • 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 August 11, 2015

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  • ACTIVE INGREDIENT

    Active ingredients (by volume)

    Isopropyl alcohol (50% conc.)

  • PURPOSE

    Purpose

    first aid antiseptic

  • INDICATIONS & USAGE

    Uses

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

    Warnings

    For external use only; flammable, keep away from fire or flame, heat, spark, electrical.

  • ASK DOCTOR

    Ask a doctor before use if you have

    • deep punctured wounds, animal bites or serious burns
  • WHEN USING

    When using this product

    • do not get into eyes
    • do not apply over large areas of the body
    • do not use longer than one week unless directed by a doctor
  • STOP USE

    Stop using this product if

    • condition persists or gets worse
  • KEEP OUT OF REACH OF CHILDREN

    Keep this and all drugs out of the reach of children

    In case of accidental ingestion, seek professional assistance or contact a Poison control center (1-800-222-1212) immediately

  • DOSAGE & ADMINISTRATION

    Directions

    • clean effected area
    • apply small amount of this product on the area 1-3 times daily
    • may be covered with a sterile bandage
    • if bandaged, let dry first
  • SPL UNCLASSIFIED SECTION

    Other information

    • store at room temperature
    • does not contain, nor is intended as a substitute for grain or ethyl alcohol
    • will produce serious gastric disturbance if taken internally
  • INACTIVE INGREDIENT

    Inactive ingredient

    Water (Aqua)

  • PRINCIPAL DISPLAY PANEL

    PRINCIPAL DISPLAY PANEL

    ISOPROPYL RUBBING ALCOHOL 50%

    FIRST AID ANTISEPTIC

    12 FL.OZ (355 mL)

    image description

  • INGREDIENTS AND APPEARANCE
    ISOPROPYL RUBBING ALCOHOL 50% 
    isopropyl alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52920-129
    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:52920-129-41118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:52920-129-42177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    3NDC:52920-129-43237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    4NDC:52920-129-44296 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    5NDC:52920-129-45354 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    6NDC:52920-129-46414 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    7NDC:52920-129-47473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/10/2015
    Labeler - Singhfam Corporation (019499958)
    Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425)
    Establishment
    NameAddressID/FEIBusiness Operations
    Anicare Pharmaceuticals Pvt. Ltd916837425manufacture(52920-129)
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