Label: QUALITY CHOICE TRIPLE ANTIBIOTIC PLUS PAIN RELIEVER- bacitracin zinc, neomycin sulfate, polymyxin-b sulfate, pramoxine hydrochloride ointment
-
Contains inactivated NDC Code(s)
NDC Code(s): 63868-945-94 - Packager: CHAIN DRUG MARKETING ASSOCIATION 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 February 9, 2012
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- PURPOSE
- WARNINGS
- DO NOT USE
- ASK DOCTOR
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
-
ACTIVE INGREDIENT
Active Ingredients (in each gram) Purpose
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 hydrochloride 10 mg........................................................................Pain reliever
-
INGREDIENTS AND APPEARANCE
QUALITY CHOICE TRIPLE ANTIBIOTIC PLUS PAIN RELIEVER
bacitracin zinc, neomycin sulfate, polymyxin-b sulfate, pramoxine hydrochloride ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63868-945 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 SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN SULFATE 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) POLYSORBATE 80 (UNII: 6OZP39ZG8H) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63868-945-94 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 02/09/2012 Labeler - CHAIN DRUG MARKETING ASSOCIATION INC (011920774)