Label: BACITRACIN ZINC ointment
Contains inactivated NDC Code(s)
NDC Code(s): 54162-017-09, 54162-017-15, 54162-017-28
- Packager: GERITREX 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.
Updated January 17, 2018
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- ACTIVE INGREDIENT
- INDICATIONS & USAGE
FOR EXTERNAL USE ONLY
Allergy Alert: Do not use if allergic to any of the ingredients.
Do not use in eyes or on large areas of the body.
Ask a doctor before use if you have deep or puncture wounds, animal bites or serious burns.
When using this product, do not use longer than 1 week, unless directed by a doctor.
Stop use and ask a doctor if condition lasts or gets worse, rahs or other allergic reaction develops.
- KEEP OUT OF REACH OF CHILDREN
- Inactive Ingredients:
- STORAGE AND HANDLING
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
bacitracin zinc ointment
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54162-017 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN 500 [iU] 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:54162-017-15 15 g in 1 TUBE; Type 0: Not a Combination Product 07/31/2015 2 NDC:54162-017-28 28 g in 1 TUBE; Type 0: Not a Combination Product 11/01/2017 3 NDC:54162-017-09 0.9 g in 1 POUCH; Type 0: Not a Combination Product 07/31/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333B 05/15/2014 Labeler - GERITREX LLC (112796248) Registrant - GERITREX LLC (112796248) Establishment Name Address ID/FEI Business Operations GERITREX LLC 112796248 manufacture(54162-017)