NDC | 71927-003-02 |
Set ID | f9d698e2-a122-48bb-8298-38c55ef36874 |
Category | HUMAN OTC DRUG LABEL |
Packager | Orazen Inc |
Generic Name | |
Product Class | Aminoglycoside Antibacterial |
Product Number | |
Application Number | PART333B |
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- DO NOT USE
- ASK DOCTOR
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- SPL UNCLASSIFIED SECTION
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
TRIPLE ANTIBIOTIC
bacitracin zinc, neomycin sulfate and polymyxin b sulfate ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71927-003 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 COCOA BUTTER (UNII: 512OYT1CRR) COTTONSEED OIL (UNII: H3E878020N) OLIVE OIL (UNII: 6UYK2W1W1E) SODIUM PYRUVATE (UNII: POD38AIF08) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) PETROLATUM (UNII: 4T6H12BN9U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71927-003-02 1 in 1 CARTON 07/12/2018 1 14.2 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 07/12/2018 Labeler - Orazen Inc (080916640) Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425) Establishment Name Address ID/FEI Business Operations Anicare Pharmaceuticals Pvt. Ltd 916837425 manufacture(71927-003)