ASTONEA MEDICATED BODY POWDER POWDER- menthol, zinc oxide powder 
ASTONEA LABS PRIVATE LIMITED

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Astonea Medicated Body Powder

Drug Facts

Active Ingredients

Menthol 0.15 %

Zinc Oxide 1.0%

Purpose

Anti-itch

Skin Protectant

Uses

for the temporary relief of the pain and itch associated with

Keep out of reach of children

Keep out of reach of children. In case of accidential ingestion, get medical help or contact a Poison Control Center right away.

Warnings

For external use only

When usin this product

Stop use and ask a doctor if

Directions

Inactive Ingredients

Corn Starch, Eucalyptol, Gum Talha, Methyl Salicylate, Salicylic Acid, Sodium Bicarbonate, Thymol, Tricalcium Phosphate, Zinc Stearate

Principal Display and Drug Fact Panel

ASTONEA MEDICATED BODY POWDER  POWDER
menthol, zinc oxide powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77338-403
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.15 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
STARCH, CORN (UNII: O8232NY3SJ)  
GUM TALHA (UNII: H18F76G097)  
EUCALYPTOL (UNII: RV6J6604TK)  
METHYL SALICYLATE (UNII: LAV5U5022Y)  
SALICYLIC ACID (UNII: O414PZ4LPZ)  
THYMOL (UNII: 3J50XA376E)  
ZINC STEARATE (UNII: H92E6QA4FV)  
TRICALCIUM PHOSPHATE (UNII: K4C08XP666)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:77338-403-10283 g in 1 BOTTLE; Type 0: Not a Combination Product10/05/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01610/05/2021
Labeler - ASTONEA LABS PRIVATE LIMITED (878533295)

Revised: 6/2024
Document Id: 1bbb5b9f-a70c-5429-e063-6394a90a1dab
Set id: e69b4924-313b-0ea5-e053-2995a90a616d
Version: 2
Effective Time: 20240625
 
ASTONEA LABS PRIVATE LIMITED