Label: WALGREENS MAXIMUM STRENGTH TRIPLE ANTIBIOTIC WITH PAIN RELIEF- bacitracin zinc, neomycin sulfate, polymyxin b sulfate, and pramoxine hcl 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 March 1, 2018

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active ingredients (each gram contains)                                               Purpose

    Bacitracin zinc 500 units.................................................................. First aid antibiotic

    Neomycin sulfate 3.5 mg.................................................................. First aid antibiotic

    Polymyxin B sulfate 10,000 units....................................................... First aid antibiotic

    Pramoxine HCI 10 mg...................................................................... External analgesic

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  • PURPOSE

    Uses

    • first aid to help prevent infection and for temporary relief of pain or discomfort due to:
    • minor cuts
    • scrapes
    • burns
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  • WARNINGS

    Warnings

    For external use only

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  • DO NOT USE

    Do not use

    • if you are allergic to any of the ingredients
    • in the eyes
    • over large areas of the body
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  • ASK DOCTOR

    Ask a doctor before use if you have

    • deep or puncture wounds
    • animal bites
    • serious burns
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  • STOP USE

    Stop use and ask a doctor if

    • you need to use longer than 1 week
    • condition persists or gets worse
    • symptoms persist for more than 1 week or clear up and occur again within a few days
    • rash or other allergic reaction develops
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  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

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  • INDICATIONS & USAGE

    Directions

    • adults and children 2 years of age and older:
    • clean the affected area
    • apply a small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily
    • may be covered with a sterile bandage
    • children under 2 years of age: ask a doctor
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  • STORAGE AND HANDLING

    Other information

    • store at 20°-25°C (68°-77°F)
    • Lot No. & Exp. Date: See box or crimp of tube
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  • INACTIVE INGREDIENT

    Inactive ingredients

    ethanol, methylparaben, mineral oil, petrolatum, polyoxyl 40 stearate, propylparaben

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  • DOSAGE & ADMINISTRATION

    Distributed by:

    Walgreen Co.

    200 Wilmot Rd.

    Deerfield, IL 60015

    Made in Korea

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  • INGREDIENTS AND APPEARANCE
    WALGREENS MAXIMUM STRENGTH TRIPLE ANTIBIOTIC WITH PAIN RELIEF 
    bacitracin zinc, neomycin sulfate, polymyxin b sulfate, and pramoxine hcl ointment
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-7872
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN 500 [USP'U]  in 1 g
    NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN 3.5 mg  in 1 g
    POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B 1000 [USP'U]  in 1 g
    PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE 10 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    ALCOHOL (UNII: 3K9958V90M)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYOXYL 40 STEARATE (UNII: 13A4J4NH9I)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0363-7872-28 1 in 1 CARTON 05/13/2015
    1 28 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333B 05/13/2015
    Labeler - Walgreen Co. (008965063)
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