NDC | 55305-123-01, 55305-123-02, 55305-123-03 |
Set ID | 2287a31c-750c-728d-e054-00144ff88e88 |
Category | HUMAN OTC DRUG LABEL |
Packager | Aero Healthcare US LLC |
Generic Name | |
Product Class | Aminoglycoside Antibacterial |
Product Number | |
Application Number | PART333B |
- ACTIVE INGREDIENT
- Purpose
- Warnings:
- KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- INACTIVE INGREDIENT
- Indications & Usage
- AST05USV2
-
INGREDIENTS AND APPEARANCE
AEROSOOTHE
triple antibiotic ointment ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55305-123 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B 5000 [iU] in 1 g BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN 400 [iU] in 1 g NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN 5 mg in 1 g Inactive Ingredients Ingredient Name Strength PETROLATUM (UNII: 4T6H12BN9U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55305-123-02 25 in 1 BOX 02/01/2016 1 NDC:55305-123-01 0.9 g in 1 PACKET; Type 0: Not a Combination Product 2 NDC:55305-123-03 0.5 g in 1 PACKET; Type 0: Not a Combination Product 10/20/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333B 10/20/2015 Labeler - Aero Healthcare US LLC (008186174)