Label: MAXIMUM STRENGTH TRIPLE ANTIBIOTIC- bacitracin zinc, neomycin sulfate, polymyxin b sulfate 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 May 21, 2021

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active Ingredients:

    (Bacitracin Zinc-Neomycin-Polymyxin B)

  • PURPOSE

    First aid antibiotic plus topical pain reliever.

  • INDICATIONS & USAGE

    Uses:

    First aid to help prevent infection and for the
    temporary relief of pain or discomfort in minor cuts,
    scrapes, and burns.

  • WARNINGS

    Warnings: For external use only.

    Do Not Use:

    • In the eyes • Over large areas of the body
    • Longer than 1 week unless directed by doctor
    • If you are allergic to any of the ingredients,
      due to the possibility of anaphylactic shock

  • STOP USE

    Stop Use and Ask a Doctor: • Before use in
    case of deep puncture wounds, animal bite or serious
    burns. • If the condition perists or gets worse. • If a
    rash or other allergic reaction develops.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN.

  • DOSAGE & ADMINISTRATION

    Directions: Clean the aff¬ected area. Apply a small
    amount of this product (an amount equal to the tip of
    a finger) on the area 1 to 3 times daily. May be covered
    with sterile bandage. Children under 2 years of age
    consult a physician.

  • OTHER SAFETY INFORMATION

    Ingredients:
    NET WT: 1 gm Each gram contains 400 units of
    Bacitracin Zinc. Neomycin Sulfate equivalent to 3.5 mg
    of Neomycin base. 5,000 units of Polymyxin B Sulfate
    in a white petrolatum base.

  • INACTIVE INGREDIENT

    Inactive Ingredients: Petrolatum, Mineral oil, Purified water

  • Principal Display Panel

    aramark

    6 ct. of 1g packets

    MAXIMUM STRENGTH TRIPLE

    ANTIBIOTIC OINTMENT

    UNIT DOSE - ANTI-INFECTION TRIPLE ACTION: BACITRACIN ZINC,
    NEOMYCIN & POLYMYXIN B.

    aramarkuniform.com

    MANUFACTURED BY:
    Aramark
    Lenexa, KS 66219 (913) 269-9611

    6 Count

    4605 6Count

    25 Count

    4605 25Count

    res

  • INGREDIENTS AND APPEARANCE
    MAXIMUM STRENGTH TRIPLE ANTIBIOTIC 
    bacitracin zinc, neomycin sulfate, polymyxin b sulfate ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81238-4605
    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
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81238-4605-16 in 1 BOX04/16/2021
    11 g in 1 PACKET; Type 0: Not a Combination Product
    2NDC:81238-4605-225 in 1 BOX04/16/2021
    21 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B12/07/2018
    Labeler - Western First Aid Safety dba Aramark (043861524)
    Registrant - Western First Aid Safety dba Aramark (043861524)
    Establishment
    NameAddressID/FEIBusiness Operations
    Yuyao Jessie Commodity Co., Ltd.529892305manufacture(81238-4605)
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