Label: FIRST AID ANTIBIOTIC- bacitracin zinc, neomycin sulfate, polymyxin b, pramoxine hcl ointment

  • NDC Code(s): 0363-0841-58, 0363-0841-64
  • Packager: Walgreen Company
  • 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 6, 2017

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

  • Active ingredients (in each gram)

    Bacitracin zinc 500 units

    Neomycin sulfate equivalent to 3.5 mg of neomycin base

    Polymyxin B 10,000 units as polymyxin B sulfate

    Pramoxine HCl 10 mg

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  • Purpose

    First aid antibiotic

    External analgesic

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  • Uses

    first aid to help prevent infection and for temporary relief of pain or discomfort in minor:

    cuts
    scrapes
    burns
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  • Warnings

    For external use only.

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  • 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 a doctor before use if you have

    deep or puncture wounds
    animal bites
    serious burns
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  • 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.

    If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).

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  • 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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  • Other information

    store at 20-25 °C (68-77 °F)
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  • Inactive ingredients

    cocoa butter, cottonseed oil, olive oil, petrolatum, sodium pyruvate, tocopheryl acetate

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  • Questions or comments?

    1-800-719-9260

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  • Package/Label Principal Display Panel

    Minimizes the appearance of scars

    Maximum strength pain & itch relief

    Long-lasting infection protection

    Compare to Neosporin® + Pain Itch Scar active ingredients

    PAIN – ITCH – SCAR

    First Aid Antibiotic Ointment

    BACITRACIN ZINC, NEOMYCIN SULFATE,

    POLYMYXIN B SULFATE, PRAMOXINE HCl

    FIRST AID ANTIBIOTIC / PAIN RELIEVING OINTMENT

    NET WT 1 OZ (28 g)

    4r0-94-first aid antibiotic ointment - 1.jpg
    4r0-94-first aid antibiotic ointment - 2.jpg
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  • INGREDIENTS AND APPEARANCE
    FIRST AID ANTIBIOTIC 
    bacitracin zinc, neomycin sulfate, polymyxin b, pramoxine hcl ointment
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-0841
    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 10000 [USP'U]  in 1 g
    PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE 10 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    COCOA BUTTER (UNII: 512OYT1CRR)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    SODIUM PYRUVATE (UNII: POD38AIF08)  
    COTTONSEED OIL (UNII: H3E878020N)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Product Characteristics
    Color YELLOW (Pale) Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0363-0841-58 1 in 1 CARTON 02/16/2017
    1 14 g in 1 TUBE; Type 0: Not a Combination Product
    2 NDC:0363-0841-64 1 in 1 CARTON 02/16/2017
    2 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 02/16/2017
    Labeler - Walgreen Company (008965063)
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