Label: TOPCARE ANTIBIOTIC PLUS PAIN RELIEF- neomycin sulfate, polymyxin b sulfate, and pramoxine hydrochloride cream
- NDC Code(s): 36800-381-01
- Packager: Topco Associates LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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Drug Label Information
Updated March 8, 2019
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- PRINCIPAL DISPLAY PANEL - 14.2 g Tube Carton
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INGREDIENTS AND APPEARANCE
TOPCARE ANTIBIOTIC PLUS PAIN RELIEF
neomycin sulfate, polymyxin b sulfate, and pramoxine hydrochloride creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:36800-381 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 [iU] 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) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:36800-381-01 1 in 1 CARTON 03/21/2012 1 14.2 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 03/21/2012 Labeler - Topco Associates LLC (006935977) Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370) Establishment Name Address ID/FEI Business Operations Taro Pharmaceuticals Inc. 206263295 MANUFACTURE(36800-381)