Label: BIOTIC-PLUS- bacitracin zinc, neomycin sulfate, polymyxin b sulfate, lidocaine ointment

  • 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 July 24, 2014

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  • SPL UNCLASSIFIED SECTION

    TAMPER EVIDENT. DO NOT USE IF PACKET IS TORN OR CUT.

    advanced Stops Pain and Prevents Infection for Cuts and Scrapes

    BIOTIC-PLUS       0.5g

  • Active ingredients

    (in each gram)

    Bacitracin zinc (400 units Bacitracin)

    Neomycin sulfate (3.5 mg neomycin)

    Polymyxin B sulfate (5000 units)

    Lidocaine .40 mg

  • Purpose

    First Aid Antibiotic

    First Aid Antibiotic

    First Aid Antibiotic

    Anesthetic

  • Uses

    First aid to help prevent infection and provide temporary relief in minor cuts, scrapes, and burns

    The Provision First Aid Line

    Manufactured for Provision Medical Products Palm Desert, CA 92211

  • Warnings

    For external use only.

    Keep out of reach of children

    If ingested, contact a Poison Control Center directly.

    Do not use

    • in eyes or over large areas of the body
    • more than 1 week unless directed by a doctor
    • if allergic to ingredients.

    Stop use, ask a doctor

    • in case of deep or puncture wounds, animal bites or serious burns
    • if conditions worsen or last more than 7 days
    • if rash or allergic reaction occurs
  • Directions

    • adults & children 2 years & older: clean affected area, apply amount (equal to surface area of a tip of finger) on area 1-3 times daily. May be covered with a sterile bandage.
    • children under 2: do not use, ask a doctor
  • Inactive ingredients

    white petrolatum

  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel
  • INGREDIENTS AND APPEARANCE
    BIOTIC-PLUS 
    bacitracin zinc, neomycin sulfate, polymyxin b sulfate, lidocaine ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69103-2400
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    bacitracin zinc (UNII: 89Y4M234ES) (bacitracin - UNII:58H6RWO52I) bacitracin400 [iU]  in 1 g
    neomycin sulfate (UNII: 057Y626693) (neomycin - UNII:I16QD7X297) neomycin3.5 mg  in 1 g
    polymyxin b sulfate (UNII: 19371312D4) (polymyxin b - UNII:J2VZ07J96K) polymyxin b5000 [iU]  in 1 g
    lidocaine (UNII: 98PI200987) (lidocaine - UNII:98PI200987) lidocaine.40 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    petrolatum (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69103-2400-10.5 g in 1 POUCH
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B07/24/2014
    Labeler - Provision Medical (036936831)
    Registrant - Safetec of America, Inc. (874965262)
    Establishment
    NameAddressID/FEIBusiness Operations
    Safetec of America, Inc.874965262MANUFACTURE(69103-2400)
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