NDC | 41163-254-20 |
Set ID | 0c8b4476-03f7-45b1-abae-b6f5a298523e |
Category | HUMAN OTC DRUG LABEL |
Packager | Supervalu Inc |
Generic Name | |
Product Class | Aminoglycoside Antibacterial |
Product Number | |
Application Number | PART333B |
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Uses
-
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
- longer than 1 week
-
Directions
Adults and children 2 years of age and older:
- clean the affected area and dry thoroughly
- 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
Children under 2 years of age: consult a doctor
- Other information
- Inactive ingredient
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 28.4g Tube Carton
-
INGREDIENTS AND APPEARANCE
EQUALINE TRIPLE ANTIBIOTIC PLUS
bacitracin zinc, neomycin sulfate, polymyxin b sulfate, and pramoxine hydrochloride ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:41163-254 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Bacitracin zinc (UNII: 89Y4M234ES) (Bacitracin - UNII:58H6RWO52I) Bacitracin 500 [iU] 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 10000 [iU] in 1 g Pramoxine hydrochloride (UNII: 88AYB867L5) (Pramoxine - UNII:068X84E056) Pramoxine hydrochloride 10 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:41163-254-20 1 in 1 CARTON 1 28.4 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333B 03/31/2012 Labeler - Supervalu Inc (006961411) Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370) Establishment Name Address ID/FEI Business Operations Taro Pharmaceuticals Inc. 206263295 MANUFACTURE(41163-254)