Label: PREMIER VALUE TRIPLE ANTIBIOTIC PLUS- bacitracin zinc, neomycin, polymyxin b sulfate, pramoxine hydrochloride ointment
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Contains inactivated NDC Code(s)
NDC Code(s): 68169-0129-5 - Packager: TAI GUK PHARM. CO., LTD.
- 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 November 4, 2010
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ACTIVE INGREDIENT
Active ingredients (in each gram) Purpose
Bacitracin zinc 500 units ......................................................................................First aid antibiotic
Neomycin 3.5 mg ................................................................................................First aid antibiotic
Polymyxin B sulfate 10,000 units ..........................................................................First aid antibiotic
Pramoxine hydrochloride 10 mg ............................................................................Pain reliever
- PURPOSE
- WARNINGS
- DO NOT USE
- ASK DOCTOR
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- INACTIVE INGREDIENT
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
PREMIER VALUE TRIPLE ANTIBIOTIC PLUS
bacitracin zinc, neomycin, polymyxin b sulfate, pramoxine hydrochloride ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68169-0129 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN ZINC 500 [USP'U] in 1 g NEOMYCIN (UNII: I16QD7X297) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN 3.5 mg in 1 g POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B SULFATE 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 PETROLATUM (UNII: 4T6H12BN9U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68169-0129-5 1 in 1 CARTON 1 28 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333B 11/04/2010 Labeler - TAI GUK PHARM. CO., LTD. (631101656) Registrant - UNITED EXCHANGE CORP. (840130579) Establishment Name Address ID/FEI Business Operations TAI GUK PHARM. CO., LTD. 631101656 manufacture