Label: FAMILY WELLNESS FIRST AID ANTIBIOTIC- family wellness bacitracin zinc, polymyxin b sulfate ointment
- NDC Code(s): 69396-037-04, 69396-037-05
- Packager: Trifecta Pharmaceuticals USA, 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 January 17, 2023
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- Active Ingredient
- Purpose
- Active Ingredient
- Purpose
- Uses
- Warnings
- Stop use and ask doctor if:
- KEEP OUT OF REACH OF CHILDREN
- Directions:
- Other Information
- Inactive Ingredients
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DISTRIBUTED BY: MIDWOOD BRANDS, LLC.
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This Product is not manufactured or distributed by Johnson & Johnson Consumer Products Company, owner of the registered trademark Polysporin®
MADE IN CHINA
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INGREDIENTS AND APPEARANCE
FAMILY WELLNESS FIRST AID ANTIBIOTIC
family wellness bacitracin zinc, polymyxin b sulfate ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69396-037 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 10000 [USP'U] in 1 g BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN 500 [USP'U] in 1 g Inactive Ingredients Ingredient Name Strength MINERAL OIL (UNII: T5L8T28FGP) PETROLATUM (UNII: 4T6H12BN9U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69396-037-05 1 in 1 BOX 08/30/2019 1 15 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:69396-037-04 1 in 1 BOX 01/10/2020 2 14.2 g in 1 TUBE; 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 08/29/2019 Labeler - Trifecta Pharmaceuticals USA, LLC (079424163)