GALENTIC VITAMIN A D- petrolatum ointment

Galentic Vitamin A D by

Drug Labeling and Warnings

Galentic Vitamin A D by is a Otc medication manufactured, distributed, or labeled by Galentic Pharma (India) Priva Te Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient                               Purpose

White Petrolatum USP (76%)            Skin Protectant

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:

For External Use Only

When using this product:

• Do not get in eyes
  

Stop use and ask a doctor if:

• If condition worsens
• symptoms last more than 7 days or clear up and occur again in a few days
  

Do not use:

Do not use:

• Deep or puncture wounds
• animal bites
• serious burns

Keep out of reach of children

Keep out of reach of children

• If swallowed, get medical help or contact a Poison Control Center right away.
  

Directions for diaper rash:

• Change wet and soiled diapers promptly
• Cleanse the diaper area and allow to dry
• Apply as needed
  

Other information:

• Store at room temperature 15 deg C to 30 deg C    59 deg F to 86 deg F
• Avoid excessive heat
  

Inactive Ingredients:

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

Principal Display Panel

Galentic Vit AD.jpg

INGREDIENTS AND APPEARANCE

GALENTIC VITAMIN A D 
petrolatum ointment

Product 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)