Label: FIRST AID ONLY TRIPLE ANTIBIOTIC- bacitracin zinc, polymyxin b sulfate, neomycin sulfate ointment

  • Category: HUMAN OTC DRUG LABEL

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 November 12, 2019

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  • Active ingredients

    Bacitracin zinc 400 units

    Neomycin sulfate (5 mg equivalent to 3.5 mg Neomycin base)

    Polymyxin B sulfate 5000 units

  • Purpose

    First aid antibiotic

    First aid antibiotic

    First aid antibiotic

  • Uses

    First aid to help prevent infection in minor •cuts •scrapes •burns

  • Warnings

    For external use only

    Do not use

    • in the eyes • over large areas of the body •if you are allergic to any of the ingredients •longer than 1 week unless directed by a doctor •on deep lacerations or puncture wounds, animal bites, or serious burns

    Stop use and ask a doctor if •condition persists or gets worse, •a rash or allergic reaction occurs, •the condition persists for more than 7 days

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

  • DOSAGE & ADMINISTRATION

    Adults and Children Clean the affected area, apply a small amount of this product

    (equal to the surface area of a fingertip) 1 to 3 times daily.

  • Other information

    Store at room temperature.

  • Inactive ingredient

    petrolatum

  • Questions or comments?

    Questions 1.800.835.2263

  • Principal Display Panel

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  • INGREDIENTS AND APPEARANCE
    FIRST AID ONLY TRIPLE ANTIBIOTIC 
    bacitracin zinc, polymyxin b sulfate, neomycin sulfate ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0924-5605
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN417.8 [iU]  in 1 g
    POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B5322.8 [iU]  in 1 g
    NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN3.5 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0924-5605-07144 in 1 BOX, UNIT-DOSE11/12/2019
    10.5 g in 1 PACKET; Type 0: Not a Combination Product
    2NDC:0924-5605-0525 in 1 BOX, UNIT-DOSE11/12/2019
    20.5 g in 1 PACKET; Type 0: Not a Combination Product
    3NDC:0924-5605-0660 in 1 CARTON11/12/2019
    30.5 g in 1 PACKET; Type 0: Not a Combination Product
    4NDC:0924-5605-0412 in 1 CARTON11/12/2019
    40.5 g in 1 PACKET; Type 0: Not a Combination Product
    5NDC:0924-5605-0310 in 1 CARTON11/12/2019
    50.5 g in 1 PACKET; Type 0: Not a Combination Product
    6NDC:0924-5605-010.5 g in 1 PACKET; Type 0: Not a Combination Product11/12/2019
    7NDC:0924-5605-026 in 1 BAG11/12/2019
    70.5 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B11/12/2019
    Labeler - Acme united Corporation (001180207)
    Establishment
    NameAddressID/FEIBusiness Operations
    Acme United Corporation045924339relabel(0924-5605) , repack(0924-5605)
    Establishment
    NameAddressID/FEIBusiness Operations
    Acme United Corporation080119599relabel(0924-5605) , repack(0924-5605)
    Establishment
    NameAddressID/FEIBusiness Operations
    Water-Jel Technologies155522589manufacture(0924-5605)
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