Label: BACITRACIN ZINC, NEOMYCIN SULFATE AND POLYMYXIN B SULFATE ointment
-
Contains inactivated NDC Code(s)
NDC Code(s): 68786-216-01, 68786-216-02, 68786-216-03, 68786-216-04, view more68786-216-05 - Packager: Sion Biotext Medical Ltd
- 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 July 9, 2012
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- Uses:
- Ask a doctor before use:
- 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:68786-216 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN ZINC - UNII:89Y4M234ES) BACITRACIN ZINC 400 [iU] in 1 g NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN SULFATE 5 mg in 1 g POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B SULFATE 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:68786-216-05 72 in 1 CASE 1 28.35 g in 1 TUBE 2 NDC:68786-216-01 12 in 1 CASE 2 144 in 1 BOX 2 0.9 g in 1 PACKET 3 NDC:68786-216-03 12 in 1 CASE 3 144 in 1 BOX 3 0.5 g in 1 PACKET 4 NDC:68786-216-04 1728 in 1 CASE 4 0.5 g in 1 PACKET 5 NDC:68786-216-02 1728 in 1 CASE 5 0.9 g in 1 PACKET Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333B 07/09/2012 Labeler - Sion Biotext Medical Ltd (532775194) Establishment Name Address ID/FEI Business Operations Sion Biotext Medical Ltd 532775194 manufacture