ASTONEA VITAMIN A AND D- white petrolatum ointment

Astonea by

Drug Labeling and Warnings

Astonea by is a Otc medication manufactured, distributed, or labeled by ASTONEA LABS PRIVATE LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

White Petroleum Jelly 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

Cholecalciferol, Lanolin, Light Mineral Oil, Microcrystalline Wax, Paraffin, Vitamin A Palmitate

Package Label

INGREDIENTS AND APPEARANCE

ASTONEA  VITAMIN A AND D
white petrolatum ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77338-307
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)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
LIGHT MINERAL OIL (UNII: N6K5787QVP)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
CHOLECALCIFEROL (UNII: 1C6V77QF41)
PARAFFIN (UNII: I9O0E3H2ZE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77338-307-02	5 g in 1 PACKET; Type 0: Not a Combination Product	05/23/2013
2	NDC: 77338-307-03	28.3 g in 1 TUBE; Type 0: Not a Combination Product	05/23/2013
3	NDC: 77338-307-04	113 g in 1 TUBE; Type 0: Not a Combination Product	05/23/2013
4	NDC: 77338-307-05	425 g in 1 JAR; Type 0: Not a Combination Product	05/23/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	05/23/2013

Labeler - ASTONEA LABS PRIVATE LIMITED (878533295)

Establishment
Name	Address	ID/FEI	Business Operations
ASTONEA LABS PRIVATE LIMITED		878533295	manufacture(77338-307)