Label: AFTATE TRIPLE ANTIBIOTIC- triple antibiotic ointment 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 April 1, 2016

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

  • DOSAGE & ADMINISTRATION

    dosage directions

  • INDICATIONS & USAGE

    uses

  • WARNINGS

    warnings part 2warnings part 1

  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach

  • ACTIVE INGREDIENT

    active ingredients

  • INACTIVE INGREDIENT

    inactive ingredient

  • PURPOSE

    purpose

  • PRINCIPAL DISPLAY PANEL

    princple display

  • INGREDIENTS AND APPEARANCE
    AFTATE TRIPLE ANTIBIOTIC 
    triple antibiotic ointment ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70356-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B5000 [iU]  in 1 g
    NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN3.5 mg  in 1 g
    BACITRACIN ZINC (UNII: 89Y4M234ES) (Bacitracin - UNII:58H6RWO52I) Bacitracin400 [iU]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70356-101-0128 g in 1 TUBE; Type 0: Not a Combination Product05/01/2016
    2NDC:70356-101-0514 g in 1 TUBE; Type 0: Not a Combination Product05/01/2016
    3NDC:70356-101-339.4 g in 1 TUBE; Type 0: Not a Combination Product05/01/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B05/01/2016
    Labeler - Sabel Med LLC (091476000)