Label: AFTATE TRIPLE ANTIBIOTIC- triple antibiotic ointment ointment
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Contains inactivated NDC Code(s)
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
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- DOSAGE & ADMINISTRATION
- INDICATIONS & USAGE
- WARNINGS
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- ACTIVE INGREDIENT
- INACTIVE INGREDIENT
- PURPOSE
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
AFTATE TRIPLE ANTIBIOTIC
triple antibiotic ointment ointmentProduct 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)
