Label: CVS HEALTH TRIPLE ANTIBIOTIC WITH PAIN RELIEF- bacitracin zinc, polymyxin b sulfate, neomycin sulfate and pramoxine hcl ointment
- NDC Code(s): 69842-161-10
- Packager: CVS Health
- 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 September 8, 2017
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- Active ingredients (In each gram)
- Purpose
- Uses
- Warnings
- Directions
- Other information
- Inactive ingredient
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INGREDIENTS AND APPEARANCE
CVS HEALTH TRIPLE ANTIBIOTIC WITH PAIN RELIEF
bacitracin zinc, polymyxin b sulfate, neomycin sulfate and pramoxine hcl ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69842-161 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Bacitracin Zinc (UNII: 89Y4M234ES) (Bacitracin - UNII:58H6RWO52I) Bacitracin 500 [USP'U] in 1 g Polymyxin B Sulfate (UNII: 19371312D4) (Polymyxin B - UNII:J2VZ07J96K) Polymyxin B 10000 [USP'U] in 1 g Neomycin Sulfate (UNII: 057Y626693) (Neomycin - UNII:I16QD7X297) Neomycin 3.5 mg in 1 g PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE 10 mg in 1 g Inactive Ingredients Ingredient Name Strength Petrolatum (UNII: 4T6H12BN9U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69842-161-10 24 in 1 CARTON 04/28/2017 1 0.9 g in 1 PACKET; 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 04/28/2017 Labeler - CVS Health (062312574) Registrant - Sheffield Pharmaceuticals LLC (151177797) Establishment Name Address ID/FEI Business Operations Sheffield Pharmaceuticals LLC 151177797 MANUFACTURE(69842-161)