Label: AMERICAN SAFETY AND FIRST AID TRIPLE ANTIBIOTIC- bacitracin zinc, neomycin sulfate, polymyxin b sulfate ointment
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Contains inactivated NDC Code(s)
NDC Code(s): 71927-016-01, 71927-016-02 - Packager: Orazen Inc
- 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 October 15, 2022
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredients
- Purpose
- Uses
- Warning
- DO NOT USE
- Ask a doctor before use if you have
- STOP USE
- Keep out of reach of children.
- Directions
- Inactive Ingredient
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
AMERICAN SAFETY AND FIRST AID TRIPLE ANTIBIOTIC
bacitracin zinc, neomycin sulfate, polymyxin b sulfate ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71927-016 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN 400 [USP'U] in 1 g NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN 0.0035 g in 1 g POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B 5000 [USP'U] in 1 g Inactive Ingredients Ingredient Name Strength MINERAL OIL (UNII: T5L8T28FGP) PETROLATUM (UNII: 4T6H12BN9U) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71927-016-02 25 in 1 BOX 10/17/2022 1 NDC:71927-016-01 0.5 g in 1 POUCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333B 10/17/2022 Labeler - Orazen Inc (080916640)
