Label: AFTATE TRIPLE ANTIBIOTIC- triple antibiotic ointment ointment

  • NDC Code(s): 70356-101-01, 70356-101-05, 70356-101-33
  • Packager: Sabel Med LLC
  • 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.

  • INGREDIENTS AND APPEARANCE
    AFTATE TRIPLE ANTIBIOTIC 
    triple antibiotic ointment ointment
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:70356-101
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B 5000 [iU]  in 1 g
    NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN 3.5 mg  in 1 g
    BACITRACIN ZINC (UNII: 89Y4M234ES) (Bacitracin - UNII:58H6RWO52I) Bacitracin 400 [iU]  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:70356-101-01 28 g in 1 TUBE; Type 0: Not a Combination Product 05/01/2016
    2 NDC:70356-101-05 14 g in 1 TUBE; Type 0: Not a Combination Product 05/01/2016
    3 NDC:70356-101-33 9.4 g in 1 TUBE; Type 0: Not a Combination Product 05/01/2016
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333B 05/01/2016
    Labeler - Sabel Med LLC (091476000)
    Close