Label: ISOPROPYL- 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 June 1, 2017

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

  • Active Ingredients

    Isopropyl Alcohol 50%

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  • Purpose

    First aid antiseptic

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  • Uses

    helps prevent the rist of infection in:

    • minor cuts
    • scrapes
    • burns
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  • Warnings

    for external use only

    Flammable - keep away from fire or flame, hea, spark, electrical

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  • ask a doctor before use

    for deep wonds, animal bites or serious burns

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  • when using this product

    • do not get into eyes
    • do not apply over large areas of the body
    • do not use longher than 1 week unless directed by a doctor
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  • stop use and ask a doctor if

    condition persists or gets worse

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  • Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center right away.

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  • Other information

    Caution-Do not apply to irritated skin or if excessive irritation develops.  Avoid gettng in to the eyes or on mucous membranes

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  • Directions

    • clean the affected area
    • apply a small amount of this product on the affected area 1 to 3 times daily
    • may be covered with a sterile bandage
    • if bandaged, let dry first
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  • Other information

    • does not contain, nore is intended as a substitute for grain or ethyl alcohol
    • will produce serious gastric disturbances if taken internally
    • fumes can be acutely irritating to respiratory system.  Avoid inhaling this product.
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  • Inactive ingredients

    blue 1, methyl salicylate, water, yellow5

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  • Adverse Reactions

    Distributed by: Vi-Jon

    One Swan Drive, Smyrna, TN 37167

    211.002/211AC

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  • principal display panel

    NDC 0869-0211-43

    Swan

    50%

    Isopropyl Alcohol

    • With Wintergreen
    • First Aid Antiseptic
    • For Rubbing & Massaging

    Square bottle uses less plastic

    than a similarly sized round bottle.

    Recyclable (if available in your area)

    WARNING FLAMMABLE Keep away from heat, spark, electrical, fire or flame

    Use only in a well-ventilated area; fumes may be harmful

    16 FL OZ (1 PT) 473 mL

    image description

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  • Alternate principal display panel

    mountain

    falls

    50%

    isopropyl

    alcohol with wintergreen

    first aid antiseptic

    WARNING FLAMMABLE - Keep away from heat, spark, electrical, fire or flame

    Use only in a well-ventilated area; fumes can be harmful

    CAUTION: do not point at self or others;

    product will squirt when squeezed.

    12 FL OZ (355 mL)

    image description

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  • INGREDIENTS AND APPEARANCE
    ISOPROPYL 
    isopropyl alcohol liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0869-0211
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL 924 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    WATER (UNII: 059QF0KO0R)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0869-0211-43 473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 09/30/2004
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333A 09/30/2004
    Labeler - Vi-Jon (790752542)
    Registrant - Vi-Jon (790752542)
    Establishment
    Name Address ID/FEI Business Operations
    Vi-Jon 790752542 manufacture(0869-0211)
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