AG INTERNATIONAL VITAMIN A AND D- white petrolatum ointment

AG INTERNATIONAL by

Drug Labeling and Warnings

AG INTERNATIONAL by is a Otc medication manufactured, distributed, or labeled by AG International. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

White Petrolatum USP (76% 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, espicially at bedtime when exposure to wet diapers may be prolonged

Warnings

For external use only

When using this product

■ do not get into eyes

Stop use and ask a doctor if

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

Do not use on

■ animal bites ■ deep or puncture wounds ■ 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 59-86F (15-30C) ■ avoid excessive heat and humidity

Inactive ingredients

lanolin, lavender oil, light liquid paraffin, vitamin A, vitamin D

Package Label

INGREDIENTS AND APPEARANCE

AG INTERNATIONAL  VITAMIN A AND D
white petrolatum ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73235-3045
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	76 g  in 100 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: 73235-3045-2	5 g in 1 PACKET; Type 0: Not a Combination Product	07/23/2019
2	NDC: 73235-3045-3	28.3 g in 1 TUBE; Type 0: Not a Combination Product	07/23/2019
3	NDC: 73235-3045-4	113 g in 1 TUBE; Type 0: Not a Combination Product	07/23/2019
4	NDC: 73235-3045-5	425 g in 1 JAR; Type 0: Not a Combination Product	07/23/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	07/23/2019

Labeler - AG International (675480459)