Label: SHOPKO TRIPLE ANTIBIOTIC- bacitracin zinc, neomycin sulfate, polymyxin-b sulfate ointment
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Contains inactivated NDC Code(s)
NDC Code(s): 68169-0022-8 - 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 December 20, 2010
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ACTIVE INGREDIENT
Active Ingredients (each gram contains) Purpose
Bacitracin zinc 400 units ........................................................................................Antibiotic
Neomycin Sulfate equivalent to 3.5mg of Neomycin Base ........................................Antibiotic
Polymyxin-B Sulfate 5000 units ..............................................................................Antibiotic
- 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
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INGREDIENTS AND APPEARANCE
SHOPKO TRIPLE ANTIBIOTIC
bacitracin zinc, neomycin sulfate, polymyxin-b sulfate ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68169-0022 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN ZINC - UNII:89Y4M234ES) BACITRACIN ZINC 400 [iU] 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 5000 [iU] in 1 g Inactive Ingredients Ingredient Name Strength MINERAL OIL (UNII: T5L8T28FGP) METHYLPARABEN (UNII: A2I8C7HI9T) POLYOXYL 40 STEARATE (UNII: 13A4J4NH9I) PROPYLPARABEN (UNII: Z8IX2SC1OH) PETROLATUM (UNII: 4T6H12BN9U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68169-0022-8 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 12/20/2010 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