Label: FACE VALUES TRIPLE ANTIBIOTIC- bacitracin, neomycin sulfate, polymyxin-b sulfate ointment
-
Contains inactivated NDC Code(s)
NDC Code(s): 63940-542-28 - Packager: HARMON STORES 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 April 1, 2012
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
-
ACTIVE INGREDIENT
Active Ingredients (each gram contains) Purpose
Bacitracin 400 units ...............................................................................................First Aid Antibiotic
Neomycin Sulfate equivalent to 3.5mg of Neomycin Base..........................................First Aid Antibiotic
Polymyxin-B Sulfate 5000 units ..............................................................................First Aid 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
-
INGREDIENTS AND APPEARANCE
FACE VALUES TRIPLE ANTIBIOTIC
bacitracin, neomycin sulfate, polymyxin-b sulfate ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63940-542 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BACITRACIN (UNII: 58H6RWO52I) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN 400 [iU] in 1 g NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN 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:63940-542-28 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 04/01/2012 Labeler - HARMON STORES INC. (804085293)