Label: REDIWIPES ANTISEPTIC CLEANING TOWELETTES- bzk antiseptic wipes swab

  • NDC Code(s): 71105-323-01, 71105-323-02, 71105-323-03
  • Packager: Redicare LLC
  • 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 July 27, 2017

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  • Active Ingredients...................................Uses

    Benzalkonium Chloride 0.13%................................First Aid Antiseptic

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  • Uses:

    Antiseptic cleansing of face, hands and body to decrease bacteria on skin without soap and water. Antiseptic to help prevent further infection in minor cuts, scrapes, and burns.

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  • Warnings

    For external use only.

    Do not use:

    • In the eyes. If this happens, rinse thoroughly with water.
    • Over large areas of the body
    • Longer than 1 week unless directed by a doctor

    Stop use and ask doctor if:

    • Irritation of redness develop and persists for more than 72 hours.
    • the condition persists or gets worse

    Keep out of reach of children:

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

    Ask a doctor before use if you have:

    • Deep or puncture wounds
    • Animal bites
    • Serious burns
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  • Directions:

    Tear open packet, unfold and use as a washcloth. Allow hands to dry without wiping.

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  • Inactive Ingredients:

    purified water, sodium bicarbonate

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  • Other information:

    • For external use only.
    • Store at room temperature
    • Do not use if packet is torn or opened
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  • INGREDIENTS AND APPEARANCE
    REDIWIPES ANTISEPTIC CLEANING TOWELETTES 
    bzk antiseptic wipes swab
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:71105-323
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 0.13 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:71105-323-03 1 in 1 BOX 03/31/2017
    1 NDC:71105-323-02 25 in 1 PACKET
    1 NDC:71105-323-01 1.5 g in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333A 03/31/2017
    Labeler - Redicare LLC (800149346)
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