NDC | 50382-005-01, 50382-005-02, 50382-005-03, 50382-005-04 |
Set ID | 68449090-6c59-4046-b721-ebe572de0595 |
Category | HUMAN OTC DRUG LABEL |
Packager | Galentic Pharma (India) Priva Te Limited |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART333B |
- ACTIVE INGREDIENT
- Purpose:
-
Warnings:
For external use only
Dosage and Administration
Directions:
- clean the affected areas
- apply a small amount of product (an amountb equal to the surface area of the tip of the finger) on the area 1 to 3 times daily.
- may be covered with a sterile bandage
Stop Use and ask a doctor if:
- the condition persists or gets worse, or if a rash or other allergic reaction develops.
- Ask a doctor before use:
- Other information
- Inactive ingredients
- Principal Display Panel
-
INGREDIENTS AND APPEARANCE
BACITRACIN
bacitracin ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50382-005 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BACITRACIN (UNII: 58H6RWO52I) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN 500 [iU] in 1 g Inactive Ingredients Ingredient Name Strength MINERAL OIL (UNII: T5L8T28FGP) PETROLATUM (UNII: 4T6H12BN9U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50382-005-01 28.35 g in 1 TUBE 2 NDC:50382-005-02 14.17 g in 1 TUBE 3 NDC:50382-005-03 56.7 g in 1 TUBE 4 NDC:50382-005-04 113.4 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333B 08/02/2013 Labeler - Galentic Pharma (India) Priva Te Limited (918531450) Establishment Name Address ID/FEI Business Operations Galentic Pharma (India) Priva Te Limited 918531450 manufacture(50382-005)