Label: TRIPLE ANTIBIOTIC PLUS- bacitracin zinc, neomycin sulfate, polymyxin b sulfate and pramoxine hydrochloride ointment
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Contains inactivated NDC Code(s)
NDC Code(s): 41250-961-14, 41250-961-28, 41250-961-56 - Packager: Meijer, 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 December 18, 2018
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ACTIVE INGREDIENT
Active ingredients (in each gram) Purposes
Bacitracin zinc 500 units........................First Aid antibiotic
Neomycin sulfate 3.5 mg.......................First Aid antibiotic
Polymyxin B sulfate 10,000 units...........First Aid antibiotic
Pramoxine HCl 10 mg............................First Aid antibiotic
- PURPOSE
- WARNINGS
- DO NOT USE
- ASK DOCTOR
- STOP USE
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- QUESTIONS
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
TRIPLE ANTIBIOTIC PLUS
bacitracin zinc, neomycin sulfate, polymyxin b sulfate and pramoxine hydrochloride ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:41250-961 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN SULFATE 3.5 mg in 1 g PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE 10 mg in 1 g BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN 500 [iU] in 1 g POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B 10000 [iU] in 1 g Inactive Ingredients Ingredient Name Strength MINERAL OIL (UNII: T5L8T28FGP) ALCOHOL (UNII: 3K9958V90M) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) POLYOXYL 40 STEARATE (UNII: 13A4J4NH9I) PETROLATUM (UNII: 4T6H12BN9U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:41250-961-14 1 in 1 CARTON 12/18/2018 1 14 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:41250-961-56 2 in 1 CARTON 12/18/2018 2 28 g in 1 TUBE; Type 0: Not a Combination Product 3 NDC:41250-961-28 1 in 1 CARTON 12/18/2018 3 28 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 12/18/2018 Labeler - Meijer, Inc. (006959555)