Label: ALCOHOL PREP PAD- isopropyl alcohol swab

  • 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 January 14, 2013

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  • Active Ingredient

    Isopropyl Alcohol 70% v/v

  • Inactive Ingredient

    Purified Water

  • Purpose

    Antiseptic

  • Use

    For Preparation of skin prior to injection

  • Keep Out of Reach of Children

    Keep out of reach of children

  • Directions

    Wipe Injection site vigorously and discard

  • Warnings

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

    Do not use

    • With electrocautary procedures
    • In the eyes.  
    Stop use if irritation or redness develop.  If the condition persists for more than 72 hours consult a doctor.
    If swallowed, get medical help or contact a Poison Control Center right away.
  • Package Label

    Latex Free Alcohol Prep Pad  Antiseptic

    Buttner-Frank GmbH  Am Wolfsmantel 9-11  91058 Erlangen, Germany

    Contents: 1 Pad  LOT_____________ EXP _________________  NDC _____________________

    Tear Here

    Swab Label

  • INGREDIENTS AND APPEARANCE
    ALCOHOL PREP PAD 
    isopropyl alcohol swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36769-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL.70 mg  in 1 mg
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:36769-001-01300 mg in 1 PACKET
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A02/04/2011
    Labeler - Büttner-Frank GmbH Arzt- und Krankenhausbedarf - Krankenpflege und Einmalartikel (318446978)
    Registrant - Büttner-Frank GmbH Arzt- und Krankenhausbedarf - Krankenpflege und Einmalartikel (318446978)
    Establishment
    NameAddressID/FEIBusiness Operations
    Büttner-Frank GmbH Arzt- und Krankenhausbedarf - Krankenpflege und Einmalartikel318446978manufacture(36769-001) , label(36769-001) , pack(36769-001)
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