ASTONEA EN SHIELD ALOE SOFT VITAMIN ENRICHED- zinc oxide cream

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

Zinc Oxide (3.8%w/w)

Purpose

Skin Protectant

Uses

■ helps treat and prevent diaper rash ■ temporarily protects minor ■ cuts ■ scrapes ■ burns dries the oozing and weeping of: ■ Poison ivy ■ poison oak ■ poison sumac

Warnings

For external use only

When using this product

■ do not get into eyes

Stop Use and ask a doctor if

conditions worsen symptoms last more than 7 days or clear up and occur again in a few days, consult a physician

Keep out of reach of children

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

Directions

■ change wet and soiled diapers promptly ■ cleanse the diaper area and allow to dry ■ apply ointment liberally with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged ■ for poison ivy, oak and sumac ■ apply ointment liberally as needed

Other Information

■ store at room temperature 15-30C (59-86F) ■ avoid excessive heat

Inactive ingredients

Aloe Vera Leaf, Alpha-Tocopherol, Ceteth-20, Cetostearyl Alcohol, Cetyl Alcohol, Cholecalciferol, Ethylhexylglycerin,FD&C Yellow No. 5, Fragrance, Glycerin, Lanolin, Microcrystalline Wax, Mineral Oil, Paraffin, Phenoxyethanol, Ponceau 4R, Propylene Glycol, Sodium Benzoate, Vitamin A Palmitate, Water

Package Label

INGREDIENTS AND APPEARANCE

ASTONEA  EN SHIELD ALOE SOFT VITAMIN ENRICHED
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77338-306
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	3.8 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
CETETH-20 (UNII: I835H2IHHX)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETYL ALCOHOL (UNII: 936JST6JCN)
CHOLECALCIFEROL (UNII: 1C6V77QF41)
GLYCERIN (UNII: PDC6A3C0OX)
LANOLIN (UNII: 7EV65EAW6H)
MINERAL OIL (UNII: T5L8T28FGP)
PARAFFIN (UNII: I9O0E3H2ZE)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
PONCEAU 4R (UNII: Z525CBK9PG)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77338-306-64	99.2 g in 1 TUBE; Type 0: Not a Combination Product	02/07/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	02/07/2019

Labeler - ASTONEA LABS PRIVATE LIMITED (878533295)