NDC | 63940-542-28 |
Set ID | 3dbef234-dd37-4cef-b85c-8d6c49dfa879 |
Category | HUMAN OTC DRUG LABEL |
Packager | HARMON STORES INC. |
Generic Name | |
Product Class | Aminoglycoside Antibacterial |
Product Number | |
Application Number | PART333B |
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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)