ASTONEA XERO- skin protectant ointment

ASTONEA XERO by

Drug Labeling and Warnings

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

Drug Details [pdf]

​Active Ingredients:

Zinc Oxide 15%

Dimethicone 1%

Purpose:

Skin Protectant

Uses:

• Helps treat and prevent diaper rash.
• Protects minor skin irritation associated with

diaper rash and helps seal out wetness.

​Warnings:

• For external use only,
• Avoid contact with eyes, In case of contact, flush thoroughly with water.

Warnings:

Stop use and ask a doctor If

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

Warnings:

Keep out of reach of children.

In case of accidental ingestion contact a physician or Poison Control Center right away.

Directions:

• Change wet and soiled diapers promptly, cleanse the diaper area and allow to dry.
• Apply cream liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged.

Other Information:

• Store between 15-30 °C

Inactive Ingredients:

Aloe vera Extract, Cholecalciferol, Eugenia Caryophyllus Flower Oil, Lanolin, Light Liquid Paraffin, Petrolatum, Retinyl Palmitate,Tocopheryl Acetate

Label Principal Display Panel

INGREDIENTS AND APPEARANCE

ASTONEA XERO 
skin protectant ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77338-022
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	15 g  in 100 g
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PETROLATUM (UNII: 4T6H12BN9U)
LIGHT MINERAL OIL (UNII: N6K5787QVP)
CHOLECALCIFEROL (UNII: 1C6V77QF41)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CLOVE LEAF OIL (UNII: VCA5491KVF)
LANOLIN (UNII: 7EV65EAW6H)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77338-022-23	113 g in 1 TUBE; Type 0: Not a Combination Product	08/18/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	08/18/2022

Labeler - ASTONEA LABS PRIVATE LIMITED (878533295)