GERIGENTLE-VITAMINS A AND D- petrolatum ointment

Gerigentle-Vitamins A and D by

Drug Labeling and Warnings

Gerigentle-Vitamins A and D by is a Otc medication manufactured, distributed, or labeled by AG INTERNATIONAL. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

White Petrolatum USP (93%w/w)

Purpose

Skin Protectant

Uses

• Helps treat and prevent diaper rash
• Helps seal out wetness
• Temporarily protects minor
  • cuts
  • scrapes
  • burns
• Temporarily helps protect and relieve chapped and cracked skin or 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 wetness may be prolonged

Warnings

For external use only

When using this product

• Do not get into eyes

Stop Use and consult a doctor if

• condition worsens
• symptoms last more than 7 days
• symptoms clear up and reoccur in a few days

Do not use on

• deep puncture wounds
• animal bites
• serious burns

Keep out of reach of children! If swallowed, get medical help or contact a Poison Control Center immediately

Directions for use with Diaper Rash

• change wet and soiled diaper promptly
• cleanse the diaper area and allow to dry
• apply as needed

Other information

• store at 15°-30°C (59°-86°F)
• avoid excessive heat and humidity

Inactive Ingredients

• Lanolin, Lavender Oil, Light Liquid Paraffin, Vitamin A and Vitamin D

PRINCIPAL DISPLAY PANEL - 113 g Tube Carton

INGREDIENTS AND APPEARANCE

GERIGENTLE-VITAMINS A AND D 
petrolatum ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73235-1053
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	0.93 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
LANOLIN (UNII: 7EV65EAW6H)
LAVENDER OIL (UNII: ZBP1YXW0H8)
LIGHT MINERAL OIL (UNII: N6K5787QVP)
VITAMIN A (UNII: 81G40H8B0T)
VITAMIN D (UNII: 9VU1KI44GP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73235-1053-3	12 in 1 CARTON	01/15/2015
1		113 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 73235-1053-2	5 g in 1 PACKET; Type 0: Not a Combination Product	01/15/2015
3	NDC: 73235-1053-4	144 in 1 BOX	03/16/2020
3		5 g in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	01/15/2015

Labeler - AG INTERNATIONAL (675480459)

Establishment
Name	Address	ID/FEI	Business Operations
AG INTERNATIONAL		675480459	manufacture(73235-1053)