Label: FIRST AID ANTIBIOTIC- bacitracin zinc ointment
- NDC Code(s): 53329-089-01, 53329-089-86, 53329-089-87
- Packager: Medline Industries, LP
- 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 August 8, 2023
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- Official Label (Printer Friendly)
- Active ingredient (in each gram)
- Purpose
- Uses
-
Warnings
- For external use only
Do not use
- in the eyes
- if you are allergic to any of the ingredients, due to the possibility of anaphylactic shock
- over large areas of the body
- longer than 1 week unless directed by a doctor
- Directions
- Other information
- Inactive ingredients
- Manufacturing Information
- Package Label
-
INGREDIENTS AND APPEARANCE
FIRST AID ANTIBIOTIC
bacitracin zinc ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53329-089 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 MINERAL OIL (UNII: T5L8T28FGP) WHITE PETROLATUM (UNII: B6E5W8RQJ4) PARAFFIN (UNII: I9O0E3H2ZE) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53329-089-01 1 in 1 BOX 03/01/2010 1 28.4 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:53329-089-86 144 in 1 CARTON 03/01/2010 2 NDC:53329-089-87 0.9 g in 1 PACKET; Type 0: Not a Combination Product 3 NDC:53329-089-87 0.9 g in 1 PACKET; Type 0: Not a Combination Product 03/01/2010 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333B 03/01/2010 Labeler - Medline Industries, LP (025460908) Registrant - Medline Industries, LP (025460908)