Label: NEOSPORIN ORIGINAL- bacitracin zinc, neomycin sulfate, and polymyxin b sulfate ointment
- NDC Code(s): 69968-0056-1, 69968-0056-2
- Packager: Johnson & Johnson Consumer 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 January 11, 2023
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- PRINCIPAL DISPLAY PANEL - 28.3 g Tube Carton
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INGREDIENTS AND APPEARANCE
NEOSPORIN ORIGINAL
bacitracin zinc, neomycin sulfate, and polymyxin b sulfate ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69968-0056 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 3.5 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 LEVANT COTTONSEED OIL (UNII: N5CFT140R8) OLIVE OIL (UNII: 6UYK2W1W1E) COCOA BUTTER (UNII: 512OYT1CRR) SODIUM PYRUVATE (UNII: POD38AIF08) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) PETROLATUM (UNII: 4T6H12BN9U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69968-0056-2 1 in 1 CARTON 09/03/2016 1 14.2 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:69968-0056-1 1 in 1 CARTON 09/03/2016 2 28.3 g in 1 TUBE; 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 09/03/2016 Labeler - Johnson & Johnson Consumer Inc. (118772437)