Label: BENZALKONIUM CHLORIDE ANTISEPTIC - benzalkonium chloride swab

  • NDC Code(s): 35617-393-01
  • Packager: NANTONG STRIP MEDICAL SUPPLY CO.,LTD.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 May 26, 2010

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  • Active Ingredients

    Benzalkonium Chloride  0.4%
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  • Purpose

    Antiseptic Close
  • Use

    Prevent infection in minor scrapes
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  • Warnings

    For external use only
    Flammable,keep away for fire or flame

    Do not use:

        * In large quantities
        * over large areas of the body
        * in eyes
        * over raw or blistered areas

    Stop use and ask a doctor if conditions worsen or persist for more than 7 days or clear up and occur again within a few days.

    Keep out of reach of children.if swallowed get medical help or contact Poison control Center right away.
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  • Directions

    Adults and Children 2 year and older; Apply to cleaned affected area not more than 3 times daily.
    Children under 2 years of age ; Consult a doctor
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  • Inactive Ingredient

    Purified Water
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  • INGREDIENTS AND APPEARANCE
    BENZALKONIUM CHLORIDE ANTISEPTIC 
    benzalkonium chloride swab
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:35617-393
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 0.004 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:35617-393-01 1 in 1 PACKET
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part348 05/20/2010
    Labeler - NANTONG STRIP MEDICAL SUPPLY CO.,LTD. (546585519)
    Establishment
    Name Address ID/FEI Business Operations
    NANTONG STRIP MEDICAL SUPPLY CO.,LTD. 546585519 manufacture
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