Label: ANTIBIOTIC- neomycin, polymyxin b, pramoxine hcl cream

  • 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 September 18, 2015

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

  • Active ingredients (in each gram)

    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.

    Do not use

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

    Ask a doctor before use if you have

    deep or puncture wounds
    animal bites
    serious burns

    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

    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 or 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 o-25 oC (68 o-77 oF)
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  • Inactive ingredients

    emulsifying wax, methylparaben, mineral oil, poloxamer 188, propylene glycol, purified water, white petrolatum

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  • Questions or comments?

    1-800-719-9260

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  • Principal Display Panel

    Compare to active ingredients in Neosporin®

    Maximum Strength

    Antibiotic Cream

    NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HCl

    First Aid Antibiotic

    Pain Relieving Cream

    NET WT. 0.5 OZ (14 g)

    Antibiotic Cream Carton Image 1
    Antibiotic Cream Carton Image 2
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  • INGREDIENTS AND APPEARANCE
    ANTIBIOTIC 
    neomycin, polymyxin b, pramoxine hcl cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:37808-005
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN 3.5 mg  in 1 g
    PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE 10 mg  in 1 g
    POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B 10000 [USP'U]  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    POLOXAMER 188 (UNII: LQA7B6G8JG)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Product Characteristics
    Color WHITE Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:37808-005-58 1 in 1 CARTON
    1 14 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 09/14/2015
    Labeler - H E B (007924756)
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