Label: SIGNATURE CARE TRIPLE ANTIBIOTIC- bacitracin, neomycin, polymyxin b, 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 10, 2021

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  • 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

  • Purpose

    First aid antibiotic

    External analgesic

  • Uses

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

    •
    cuts
    •
    scrapes
    •
    burns
  • 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)

  • 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
  • Other information

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

    white petrolatum

  • Questions or comments?

    1-800-719-9260

  • Principal Display Panel

    Compare to Neosporin® + Pain Relief active ingredients

    Quality Guaranteed

    Triple Antibiotic Ointment + Pain Relief

    BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HCl

    MAXIMUM STRENGTH

    First aid antibiotic

    Pain relieving ointment

    NET WT 1 OZ (28 g)

    triple antibiotic oitnment image
  • INGREDIENTS AND APPEARANCE
    SIGNATURE CARE TRIPLE ANTIBIOTIC 
    bacitracin, neomycin, polymyxin b, pramoxine hcl ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21130-448
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN500 [USP'U]  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 B10000 [USP'U]  in 1 g
    PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE10 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    Product Characteristics
    ColorYELLOW (Translucent) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:21130-448-641 in 1 CARTON09/27/2015
    128 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B09/27/2015
    Labeler - Safeway (009137209)
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