NDC | 52599-282-82, 52599-282-83 |
Set ID | a82852eb-18e9-431a-b3d6-80abfdbf8662 |
Category | HUMAN OTC DRUG LABEL |
Packager | Curazene, LLC |
Generic Name | |
Product Class | Aminoglycoside Antibacterial |
Product Number | |
Application Number | PART333B |
- ACTIVE INGREDIENT
- INDICATIONS & USAGE
- PURPOSE
-
WARNINGS
Warnings: For external use only. Do not use: if you are allergic to any of the ingredients, in the eyes, over large areas of the body. Ask a doctor before use if you have: large puncture wounds, animal bites, serious burns.
Stop use and ask a doctor if: you need to use longer than one week, condition persists or gets worse, symptoms persist for more than one week or clear up and occur again within a few days, rash or other allergic reaction develops.
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
BACLEZENE
neomycin sulfate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52599-282 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN SULFATE 5 mg in 0.9 g Inactive Ingredients Ingredient Name Strength GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) GLYCERIN (UNII: PDC6A3C0OX) POLYSORBATE 80 (UNII: 6OZP39ZG8H) PETROLATUM (UNII: 4T6H12BN9U) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) SODIUM CITRATE (UNII: 1Q73Q2JULR) PHENOXYETHANOL (UNII: HIE492ZZ3T) METHYLPARABEN (UNII: A2I8C7HI9T) CHLORPHENESIN (UNII: I670DAL4SZ) BENZOIC ACID (UNII: 8SKN0B0MIM) ASCORBIC ACID (UNII: PQ6CK8PD0R) MAGNESIUM STEARATE (UNII: 70097M6I30) STEARIC ACID (UNII: 4ELV7Z65AP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52599-282-83 20 in 1 CARTON 06/19/2014 1 NDC:52599-282-82 0.9 g in 1 PACKET; 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 06/19/2014 Labeler - Curazene, LLC (005078008) Registrant - Curazene, LLC (005078008) Establishment Name Address ID/FEI Business Operations Ultra Seal Corp. 085752004 manufacture(52599-282)