ASTONEA XERO- skin protectant ointment 
ASTONEA LABS PRIVATE LIMITED

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ASTONEA XERO

​Active Ingredients:

Zinc Oxide 15%

Dimethicone 1%

Purpose:

Skin Protectant

Uses:

diaper rash and helps seal out wetness.

​Warnings:

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:

Other Information:

Inactive Ingredients:

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

Label Principal Display Panel

Principal Display and Drug Fact Panel

ASTONEA XERO 
skin protectant ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77338-022
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE15 g  in 100 g
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:77338-022-23113 g in 1 TUBE; Type 0: Not a Combination Product08/18/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01608/18/2022
Labeler - ASTONEA LABS PRIVATE LIMITED (878533295)

Revised: 6/2024
Document Id: 1bbb38e8-e919-5421-e063-6394a90a000e
Set id: e69ab651-9f37-8cb8-e053-2a95a90a88e3
Version: 3
Effective Time: 20240625
 
ASTONEA LABS PRIVATE LIMITED