GALENTIC VITAMIN A D- petrolatum ointment 
Galentic Pharma (India) Priva Te Limited

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Galentic Vitamin A D

Active Ingredient                               Purpose

White Petrolatum USP (76%)            Skin Protectant

Purpose:

Warnings:

For External Use Only

When using this product:

Stop use and ask a doctor if:

Do not use:

Do not use:

Keep out of reach of children

Keep out of reach of children

Directions for diaper rash:

Other information:

Inactive Ingredients:

Inactive Ingredients: Light Liquid Parafin, Vitamin A, Vitamin D

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Galentic Vit AD

GALENTIC VITAMIN A D 
petrolatum ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50382-003
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM.76 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
LANOLIN (UNII: 7EV65EAW6H)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
CHOLECALCIFEROL (UNII: 1C6V77QF41)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50382-003-01113.4 g in 1 TUBE
2NDC:50382-003-02425.25 g in 1 JAR
3NDC:50382-003-0328.35 g in 1 TUBE
4NDC:50382-003-0456.7 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34708/06/2013
Labeler - Galentic Pharma (India) Priva Te Limited (918531450)
Establishment
NameAddressID/FEIBusiness Operations
Galentic Pharma (India) Priva Te Limited918531450manufacture(50382-003)

Revised: 8/2013
Document Id: ac08d733-4b4a-4721-b701-5c8444aafc8d
Set id: a56cf1f3-e64a-455c-ac8e-22403970cb0f
Version: 2
Effective Time: 20130808
 
Galentic Pharma (India) Priva Te Limited