NDC | 63187-649-15, 63187-649-30 |
Set ID | 3e5c0f26-0b55-4868-b4f7-9c52e802fb44 |
Category | HUMAN OTC DRUG LABEL |
Packager | Proficient Rx LP |
Generic Name | |
Product Class | Aminoglycoside Antibacterial |
Product Number | |
Application Number | PART333B |
- Drug Facts
- Active ingredients (in each gram)
- Purpose
- Warnings
- For external use only
-
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- •
- clean the affected area
- •
- apply a small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily
- •
- may be covered with a sterile bandage
- PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 1/2 Oz CONTAINER
-
INGREDIENTS AND APPEARANCE
TRIPLE ANTIBIOTIC
neomycin and polymyxin b sulfates and bacitracin zinc ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63187-649(NDC:0168-0012) 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 petrolatum (UNII: 4T6H12BN9U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63187-649-15 1 in 1 CARTON 02/01/2016 1 14.17 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:63187-649-30 1 in 1 CARTON 02/01/2016 2 28.35 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 01/06/2010 Labeler - Proficient Rx LP (079196022) Establishment Name Address ID/FEI Business Operations Proficient Rx LP 079196022 RELABEL(63187-649)