Label: ISOPROPYL RUBBING ALCOHOL 70%- isopropyl alcohol liquid

  • NDC Code(s): 52000-010-01, 52000-010-02, 52000-010-03, 52000-010-04, view more
    52000-010-05, 52000-010-06, 52000-010-07
  • Packager: Universal Distribution Center LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 03/13

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

  • ACTIVE INGREDIENT

    Active Ingredients (by volume)

    Isopropyl alcohol (70% conc.)

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  • PURPOSE

    Purpose

    First aid antiseptic

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  • INDICATIONS & USAGE

    Uses

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

    Warnings

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

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  • ASK DOCTOR

    Ask a doctor before use if you have

    • deep punctured wounds, animal bites or serious burns
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  • 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
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  • STOP USE

    Stop using this product if

    • condition persists or gets worse
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  • 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

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  • 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
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  • 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
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  • INACTIVE INGREDIENT

    Inactive ingredient

    Water(Aqua)

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  • SPL UNCLASSIFIED SECTION

    PRINCIPAL DISPLAY PANEL

    ISOPROPYL RUBBING ALCOHOL 70%
    FIRST AID ANTISEPTIC
    12 FL.OZ (355 mL)

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  • INGREDIENTS AND APPEARANCE
    ISOPROPYL RUBBING ALCOHOL 70% 
    isopropyl alcohol liquid
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:52000-010
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ISOPROPYL ALCOHOL (ISOPROPYL ALCOHOL) ISOPROPYL ALCOHOL 70 mL  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:52000-010-01 118 mL in 1 BOTTLE, PLASTIC
    2 NDC:52000-010-02 177 mL in 1 BOTTLE, PLASTIC
    3 NDC:52000-010-03 237 mL in 1 BOTTLE, PLASTIC
    4 NDC:52000-010-04 296 mL in 1 BOTTLE, PLASTIC
    5 NDC:52000-010-05 355 mL in 1 BOTTLE, PLASTIC
    6 NDC:52000-010-06 414 mL in 1 BOTTLE, PLASTIC
    7 NDC:52000-010-07 473 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333A 03/15/2012
    Labeler -  Universal Distribution Center LLC (019180459)
    Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425)
    Establishment
    Name Address ID/FEI Business Operations
    Anicare Pharmaceuticals Pvt. Ltd 916837425 manufacture(52000-010)
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