Label: ALCOHOL WIPE- isopropyl alcohol swab

  • Category: HUMAN OTC DRUG LABEL

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 October 31, 2013

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  • Active ingredients

    Isopropyl Alcohol 70%

  • Purpose

    Topical Antimicrobial use

  • Use

    To prep skin prior to antimicrobial use.

  • 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.

  • Keep out of reach of children.

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

  • Directions

    Clean and discard.

  • Other information

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

  • Inactive ingredients

    purified water

  • Package/Label Principal Display Panel

    1st™ 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

  • INGREDIENTS AND APPEARANCE
    ALCOHOL WIPE 
    isopropyl alcohol swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50428-0030
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL.70 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50428-0030-51 in 1 PACKET
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/20/2010
    Labeler - Dorel Juvenile Group (118841501)
    Establishment
    NameAddressID/FEIBusiness Operations
    Shanghai Yinjin Medical Supplies Co. Ltd530501535MANUFACTURE(50428-0030)
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