Label: ALCOHOL WIPE- isopropyl alcohol swab 

  • Label RSS
  • 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 10/13

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  • Active ingredients

    Isopropyl Alcohol 70%

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  • Purpose

    Topical Antimicrobial use

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  • Use

    To prep skin prior to antimicrobial use.

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  • Warnings

    • For external use only
    • Flammable, keep away from fire or flame

    Do not use

    • With electrocautery procedures
    • In the eyes

    Stop use

    if irritation or redness develop. If the condition persists for more than 72 hours, consult a doctor.

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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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  • Directions

    Clean and discard.

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  • Other information

    Store at room temperature 15°C - 30°C (59°F - 86°F)

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  • Inactive ingredients

    purified water

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  • Package/Label Principal Display Panel

    1stâ„¢ Alcohol Wipe

    70% Isopropyl Alcohol

    EXTERNAL USE ONLY

    For Home Use only

    © 2012 Dorel Juv. Grp., Columbus, IN
    1-877-657-9545 Made in CHINA
    Model No. AL-01 NDC# 50428-0030

    Package Label

    Package Label

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  • INGREDIENTS AND APPEARANCE
    ALCOHOL WIPE 
    isopropyl alcohol swab
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:50428-0030
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ISOPROPYL ALCOHOL (ISOPROPYL ALCOHOL) ISOPROPYL ALCOHOL .70 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:50428-0030-5 1 in 1 PACKET
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333A 07/20/2010
    Labeler - Dorel Juvenile Group (118841501)
    Establishment
    Name Address ID/FEI Business Operations
    Shanghai Yinjin Medical Supplies Co. Ltd 530501535 MANUFACTURE(50428-0030)
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