Label: NEOSPORIN PLUS PAIN RELIEF FIRST AID ANTIBIOTIC/PAIN RELIEVING- neomycin sulfate, polymyxin b sulfate, and pramoxine hydrochloride cream
- NDC Code(s): 69968-0055-1, 69968-0055-2
- Packager: Johnson & Johnson Consumer Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 10, 2023
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
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- Other information
- Inactive ingredients
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- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 28.3 g Tube Carton
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INGREDIENTS AND APPEARANCE
NEOSPORIN PLUS PAIN RELIEF FIRST AID ANTIBIOTIC/PAIN RELIEVING
neomycin sulfate, polymyxin b sulfate, and pramoxine hydrochloride creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69968-0055 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength 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 10000 [USP'U] in 1 g PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE 10 mg in 1 g Inactive Ingredients Ingredient Name Strength METHYLPARABEN (UNII: A2I8C7HI9T) MINERAL OIL (UNII: T5L8T28FGP) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) PETROLATUM (UNII: 4T6H12BN9U) SODIUM HYDROXIDE (UNII: 55X04QC32I) SULFURIC ACID (UNII: O40UQP6WCF) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69968-0055-2 1 in 1 CARTON 12/01/2009 1 14.2 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:69968-0055-1 1 in 1 CARTON 12/01/2009 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 not final part348 12/01/2009 Labeler - Johnson & Johnson Consumer Inc. (118772437)