Label: BACITRACIN ZINC, NEOMYCIN SULFATE AND POLYMYXIN B SULFATE ointment
-
Contains inactivated NDC Code(s)
NDC Code(s): 50382-008-01, 50382-008-02, 50382-008-03, 50382-008-04 - Packager: Galentic Pharma (India) Private Limited
- 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 7, 2013
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- Purpose:
- Indications and Usage:
- Other information
- Inactive ingredients:
- Keep Out Of Reach Of Children
- Warnings
- Dosage and Administration
- Do Not Use:
- Stop use and ask a doctor if
- Principal Display Panel
-
INGREDIENTS AND APPEARANCE
BACITRACIN ZINC, NEOMYCIN SULFATE AND POLYMYXIN B SULFATE
bacitracin zinc, neomycin sulfate and polymyxin b sulfate ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50382-008 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN 400 [iU] in 1 g NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN 5 mg in 1 g POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B 5000 [iU] in 1 g Inactive Ingredients Ingredient Name Strength PETROLATUM (UNII: 4T6H12BN9U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50382-008-01 28.35 g in 1 TUBE 2 NDC:50382-008-02 14.17 g in 1 TUBE 3 NDC:50382-008-03 56.7 g in 1 TUBE 4 NDC:50382-008-04 113.4 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333B 08/07/2013 Labeler - Galentic Pharma (India) Private Limited (918531450)