NDC | 50382-003-01, 50382-003-02, 50382-003-03, 50382-003-04 |
Set ID | a56cf1f3-e64a-455c-ac8e-22403970cb0f |
Category | HUMAN OTC DRUG LABEL |
Packager | Galentic Pharma (India) Priva Te Limited |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART347 |
- ACTIVE INGREDIENT
-
Purpose:
- Helps treat and prevent diaper rash
- Helps seal out wetness
- Temporarily protects minor * cuts * scrapes * burns
- Temporarily helps protect and help relieve chapped and cracked skin and lips
- Helps prevent and protect from the drying effects of wind and cold weather
- Helps prevent and protect chafed skin or minor skin irritations associated with diaper rash
- With each diaper change, especially at bedtime when exposure to wet diapers may be prolonged
- Warnings:
- When using this product:
- Stop use and ask a doctor if:
- Do not use:
- Keep out of reach of children
- Directions for diaper rash:
- Other information:
- Inactive Ingredients:
- Principal Display Panel
-
INGREDIENTS AND APPEARANCE
GALENTIC VITAMIN A D
petrolatum ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50382-003 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM .76 g in 1 g Inactive Ingredients Ingredient Name Strength VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) LANOLIN (UNII: 7EV65EAW6H) LIGHT MINERAL OIL (UNII: N6K5787QVP) CHOLECALCIFEROL (UNII: 1C6V77QF41) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50382-003-01 113.4 g in 1 TUBE 2 NDC:50382-003-02 425.25 g in 1 JAR 3 NDC:50382-003-03 28.35 g in 1 TUBE 4 NDC:50382-003-04 56.7 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 08/06/2013 Labeler - Galentic Pharma (India) Priva Te Limited (918531450) Establishment Name Address ID/FEI Business Operations Galentic Pharma (India) Priva Te Limited 918531450 manufacture(50382-003)