Label: BACITRACIN ZINC ointment
-
Contains inactivated NDC Code(s)
NDC Code(s): 0168-0011-04, 0168-0011-16, 0168-0011-31, 0168-0011-35, view more0168-0111-09 - Packager: E. FOUGERA & CO., A division of Fougera Pharmaceuticals 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 August 15, 2014
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient (in each gram):
- Purpose:
- INDICATIONS & USAGE
-
WARNINGS
Warnings: For external use only
Do not use
- in the eyes
- over large areas of the body
- if you are allergic to any of the ingredients
Ask doctor before use in case of 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
- the condition persists or gets worse
- if a rash or other allergic reaction develops
- Keep out of reach of children.
- DOSAGE & ADMINISTRATION
- SPL UNCLASSIFIED SECTION
- Inactive Ingredients
- SPL UNCLASSIFIED SECTION
- PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 4 Oz CONTAINER
- PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 4 Oz Carton
- PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 1/32 Oz CONTAINER
- PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – FOILPAC CARRIER CARTON
- PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 1 lb jar CONTAINER
-
INGREDIENTS AND APPEARANCE
BACITRACIN ZINC
bacitracin zinc ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0168-0011 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 PETROLATUM (UNII: 4T6H12BN9U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0168-0011-35 1 in 1 CARTON 1 14.17 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:0168-0011-31 1 in 1 CARTON 2 28.35 g in 1 TUBE; Type 0: Not a Combination Product 3 NDC:0168-0011-04 1 in 1 CARTON 3 113.4 g in 1 TUBE; Type 0: Not a Combination Product 4 NDC:0168-0011-16 453.6 g in 1 JAR; 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 01/08/2010 BACITRACIN ZINC
bacitracin zinc ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0168-0111 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 PETROLATUM (UNII: 4T6H12BN9U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0168-0111-09 144 in 1 CARTON 1 0.9 g in 1 PACKET; 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 01/08/2010 Labeler - E. FOUGERA & CO., A division of Fougera Pharmaceuticals Inc. (043838424)