ISOPROPYL RUBBING ALCOHOL 50% (ISOPROPYL ALCOHOL) LIQUID [ UNIVERSAL DISTRIBUTION CENTER LLC]

ISOPROPYL RUBBING ALCOHOL 50% (ISOPROPYL ALCOHOL) LIQUID [ UNIVERSAL DISTRIBUTION CENTER LLC]
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NDC 52000-008-01, 52000-008-02, 52000-008-03, 52000-008-04, 52000-008-05, 52000-008-06, 52000-008-07
Set ID 010a9d81-4039-441b-b478-41ccf527e4df
Category HUMAN OTC DRUG LABEL
Packager Universal Distribution Center LLC
Generic Name
Product Class
Product Number
Application Number PART333A
  • 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)

  • SPL UNCLASSIFIED SECTION

    PRINCIPAL DISPLAY PANEL

    ISOPROPYL RUBBING ALCOHOL 50%

    FIRST AID ANTISEPTIC

    12 FL.OZ (355 mL)

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    ISOPROPYL RUBBING ALCOHOL 50% 
    isopropyl alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52000-008
    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:52000-008-01118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/13/2012
    2NDC:52000-008-02177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/13/2012
    3NDC:52000-008-03237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/13/2012
    4NDC:52000-008-04296 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/13/2012
    5NDC:52000-008-05355 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/13/2012
    6NDC:52000-008-06414 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/13/2012
    7NDC:52000-008-07473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/13/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/13/2012
    Labeler -  Universal Distribution Center LLC (019180459)
    Registrant - Universal Distribution Center LLC (019180459)
    Establishment
    NameAddressID/FEIBusiness Operations
    Anicare Pharmaceuticals Pvt. Ltd916837425manufacture(52000-008)
    Establishment
    NameAddressID/FEIBusiness Operations
    BIOTEK INDIA675484458manufacture(52000-008)

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