ASTONEA Medicated Body Powder

Manufacturer: ASTONEA LABS PRIVATE LIMITED
Effective date: 2024-06-25
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-06-01 00:14:18

Label at a glance#

ProductASTONEA Medicated Body Powder Powder

Active ingredientMENTHOL, ZINC OXIDE

Label structure10 sections

Indications and uses

for the temporary relief of the pain and itch associated with minor cuts scrapes sunburn insect bites prickly heat rashes minor burns minor skin irritations dries the oozing of poison ivy, oak and sumac.

Dosage and administration

adults and children 2 years and older, apply freely up to 3 or 4 times daily under 2 years: ask a doctor before using for best results, dry skin thoroughly before use

Label contents#

Full prescribing information#

Drug Facts Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Menthol 0.15 %

Zinc Oxide 1.0%

Purpose

OTC - PURPOSE SECTION

Anti-itch

Skin Protectant

Uses

INDICATIONS & USAGE SECTION

for the temporary relief of the pain and itch associated with

minor cuts
scrapes
sunburn
insect bites
prickly heat
rashes
minor burns
minor skin irritations
dries the oozing of poison ivy, oak and sumac.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Warnings

WARNINGS SECTION

For external use only

When usin this product

OTC - WHEN USING SECTION

Avoid contact with eyes.
Keep away from face and mouth to avoid inhalation
Not for genital area.

Stop use and ask a doctor if

OTC - STOP USE SECTION

condition worsens
symptoms do not get better within 7 days or clear up and occur again within a few days

Directions

DOSAGE & ADMINISTRATION SECTION

adults and children 2 years and older, apply freely up to 3 or 4 times daily
under 2 years: ask a doctor before using
for best results, dry skin thoroughly before use

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display and Drug Fact Panel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
577232	menthol 0.15 % / zinc oxide 1 % Topical Powder	PSN	2
577232	menthol 0.0015 MG/MG / zinc oxide 0.01 MG/MG Topical Powder	SCD	2
577232	Menthol 0.0015 MG/MG / ZNO 0.01 MG/MG Topical Powder	SY	2
577232	menthol 0.15 % / zinc oxide 1 % Topical Powder	SY	2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
77338-403-10	2024-06-25	C162847	48780-1	1030e365-5312-111a-e063-dadaa90a10e2	Astonea Medicated Body Powder
77338-403-10	2024-01-30	C162847	48780-1	1030e365-5312-111a-e063-dadaa90a10e2	Astonea Medicated Body Powder

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
77338-403-10	ASTONEA Medicated Body PowderPowder	283 g in 1 BOTTLE	POWDER	283		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
77338-403	ASTONEA MEDICATED BODY POWDER POWDER (MENTHOL, ZINC OXIDE) POWDER [ASTONEA LABS PRIVATE LIMITED]	2	Legacy NDC, 1 package rows	20240627_e69b4924-313b-0ea5-e053-2995a90a616d.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

ASTONEA Medicated Body Powder Powder
MENTHOL, ZINC OXIDE
SODIUM BICARBONATE
STARCH, CORN
GUM TALHA
EUCALYPTOL
METHYL SALICYLATE
SALICYLIC ACID
THYMOL
ZINC STEARATE
TRICALCIUM PHOSPHATE
MENTHOL
ZINC OXIDE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
77338-403	77338-403-10

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
SODIUM BICARBONATE	8MDF5V39QO	IACT
STARCH, CORN	O8232NY3SJ	IACT
GUM TALHA	H18F76G097	IACT
EUCALYPTOL	RV6J6604TK	IACT
METHYL SALICYLATE	LAV5U5022Y	IACT
SALICYLIC ACID	O414PZ4LPZ	IACT
THYMOL	3J50XA376E	IACT
ZINC STEARATE	H92E6QA4FV	IACT
TRICALCIUM PHOSPHATE	K4C08XP666	IACT
MENTHOL	L7T10EIP3A	ACTIB
ZINC OXIDE	SOI2LOH54Z	ACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
1bbb5b9f-a70c-5429-e063-6394a90a1dab			e69b4924-313b-0ea5-e053-2995a90a616d	2024-06-25	Warnings	Exact identifier spl id: 1bbb5b9f-a70c-5429-e063-6394a90a1dab spl set id: e69b4924-313b-0ea5-e053-2995a90a616d

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.