Label: BACITRACIN ZINC- bacitracin zinc ointment
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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
Directions:
- clean the affected area
- apply a small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily
- may be covered with a sterile bandage
- SPL UNCLASSIFIED SECTION
Other information:
- do not use if seal is punctured or is not visible. To open, reverse cap to puncture seal
- store at room temperature
- see crimp of tube for Lot Number and Exp. Date
- Inactive Ingredients
- SPL UNCLASSIFIED SECTION
Questions or comments? call toll free 1-800-645-9833
E. FOUGERA & CO.
A division of Fougera Pharmaceuticals Inc.
Melville, NY 11747
Close - PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 4 Oz CONTAINER
NDC 0168-0011-04
Fougera®
NET WT 113.4 g (4 Oz)
FOR HOSPITAL USE ONLY
Bacitracin Zinc Ointment USP
First Aid Antibiotic
Close - PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 4 Oz Carton
Fougera ®
Bacitracin Zinc
Ointment USPFirst Aid Antibiotic
NDC 0168-0011-04
FOR HOSPITAL USE ONLY
NET WT 113.4 g (4 Oz)
Close - PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 1/32 Oz CONTAINER
Fougera®
First Aid Antibiotic
Bacitracin Zinc
Ointment USPUses: First aid to help prevent infection
in . minor cuts . scrapes . burns
NET WT. 0.9 g (1/32 Oz)
NDC 0168-0111-09
Close - PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – FOILPAC CARRIER CARTON
NDC 0168-0111-09
Fougera ®
Bacitracin Zinc
Ointment USP
First Aid Antibiotic
This product available in tubes at pharmacy.
1 GROSS
NET WT. 0.9 g (1/32 Oz) FOILPACS®
Close - PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 1 lb jar CONTAINER
Fougera®
NDC 0168-0011-16
NET WT 453.6 g (1 lb)
Bacitracin Zinc Ointment USP
First Aid Antibiotic FOR HOSPITAL USE ONLY
Close - 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 CloseLabeler - E. FOUGERA & CO., A division of Fougera Pharmaceuticals Inc. (043838424)
