NDC | 69396-015-05, 69396-015-20 |
Set ID | d04b397c-1608-4fd9-be28-ef7285d6a996 |
Category | HUMAN OTC DRUG LABEL |
Packager | Trifecta Pharmaceuticals Usa Llc |
Generic Name | |
Product Class | Aminoglycoside Antibacterial |
Product Number | |
Application Number | PART333B |
- DRUG FACTS
- Active ingredient (each gram contains)
- Purpose
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
-
WARNINGS
Warnings For external use only.
Do not use ● in the eyes ● over large areas of the body
● if you are allergic to any of the ingredients.Ask a doctor before use if you have
● deep or puncture wounds ● animal bites ● serious burns.Stop use and ask a doctor if ● condition persists or gets worse
● you need to use longer than 1 week
● a rash or other allergic reaction develops - Directions
- INACTIVE INGREDIENT
- Other information
- QUESTIONS
- SPL UNCLASSIFIED SECTION
- Packaging
-
INGREDIENTS AND APPEARANCE
TRIPLE ANTIBIOTIC
bacitracin zinc, neomycin sulfate , polymyxin b sulfate ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69396-015 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN 400 [USP'U] 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 5000 [USP'U] in 1 g Inactive Ingredients Ingredient Name Strength LIGHT MINERAL OIL (UNII: N6K5787QVP) PETROLATUM (UNII: 4T6H12BN9U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69396-015-05 1 in 1 BOX 03/18/2016 1 15 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:69396-015-20 1 in 1 BOX 03/18/2016 2 28.4 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333B 03/18/2016 Labeler - Trifecta Pharmaceuticals Usa Llc (079424163)