Label: PREMIER VALUE BACITRACIN ZINC- bacitracin zinc ointment
- NDC Code(s): 68016-107-01
- Packager: Pharmacy Value Alliance 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 May 9, 2023
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- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Uses
- Warnings
- Do Not Use
- Ask Doctor before Use
- Stop Use and Ask Doctor if
- Directions
- Inactive Ingredients
- Questions
- Keep out of reach of children
- Other Information
- Packaging
-
INGREDIENTS AND APPEARANCE
PREMIER VALUE BACITRACIN ZINC
bacitracin zinc ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68016-107 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN 500 [USP'U] in 1 g Inactive Ingredients Ingredient Name Strength LIGHT MINERAL OIL (UNII: N6K5787QVP) PETROLATUM (UNII: 4T6H12BN9U) ALOE VERA LEAF (UNII: ZY81Z83H0X) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68016-107-01 1 in 1 BOX 12/16/2019 1 28 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 12/16/2019 Labeler - Pharmacy Value Alliance LLC (101668460) Registrant - Trifecta Pharmaceuticals USA LLC (079424163)