FDA.reportPublic FDA data

ASTONEA GREEN gel

Manufacturer
ASTONEA LABS PRIVATE LIMITED
Effective date
2024-06-25
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:14:18

Label at a glance#

ProductASTONEA GREEN gel
Active ingredientMENTHOL
Label structure7 sections

Indications and uses

Temporarily relieves minor aches and pains of muscles and joints associated with: ■Simple backache Arthritis ■Strains ■Bruises ■Sprains

Dosage and administration

■Adults and children 2 years of age and older: rub a thin film over affected area not more than 3 to 4 times daily ■Children under 2 years of age: consult a physician ■Wash hands after use with cool water

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Menthol 5%

Purpose

OTC - PURPOSE SECTION

Pain Relieving

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves minor aches and pains of muscles and joints associated with: ■Simple backache

Arthritis ■Strains ■Bruises ■Sprains

Warnings

WARNINGS SECTION

For external use only

Flammable:

SPL UNCLASSIFIED SECTION

Keep away from excessive heat or open flame.

When using this product:

OTC - WHEN USING SECTION

■Use only as directed

■Avoid contact with the eyes or on mucous membranes

■Do not apply to wounds or damaged skin

■Do not apply to irritated skin or if excessive irritation develops ■Do not bandage tightly or use with heating pad or device

Stop use and ask a doctor if:

OTC - STOP USE SECTION

■You experience pain, swelling or blistering of the skin

■Condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days

■Arthritis pain persists for more than 10 days or redness is present, or in conditions affecting children under 12 years of age

If pregnant or breast-feeding:

OTC - PREGNANCY OR BREAST FEEDING SECTION

Ask a health professional before use

Keep out of reach of children:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

■Adults and children 2 years of age and older: rub a thin film over affected area not more than 3 to 4 times daily ■Children under 2 years

of age: consult a physician ■Wash hands after use with cool water

OTHER SAFETY INFORMATION

■Store at 20˚-25˚C (68˚-77˚F)


■Store in a cool dry place away from direct sunlight

Inactive Ingredients

INACTIVE INGREDIENT SECTION

: Aloevera Extract, Arctium Lappa Root (Burdock) Extract, Arnica Montana Flower Extract, Calendula Officinalis Extract, Carbopol, FD&C Blue No. 1, FD&C Yellow No. 5, Glycerine, Green Tea Extract, Isopropyl Alcohol, Isopropyl Myristate, Silica, Triethanolamine, Vitamin E, Water

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display and Drug Fact PanelPrincipal Display and Drug Fact Panel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
415975menthol 5 % Topical GelPSN3
415975menthol 0.05 MG/MG Topical GelSCD3
415975menthol 5 % Topical GelSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
77338-015-632026-01-29C16284748780-11030e365-66f4-111a-e063-dadaa90a10e2ASTONEA GREEN PAIN GEL
77338-015-652026-01-29C16284748780-11030e365-66f4-111a-e063-dadaa90a10e2ASTONEA GREEN PAIN GEL
77338-015-672026-01-29C16284748780-11030e365-66f4-111a-e063-dadaa90a10e2ASTONEA GREEN PAIN GEL
77338-015-632024-06-25C16284748780-11030e365-66f4-111a-e063-dadaa90a10e2ASTONEA GREEN PAIN GEL
77338-015-652024-06-25C16284748780-11030e365-66f4-111a-e063-dadaa90a10e2ASTONEA GREEN PAIN GEL
77338-015-672024-06-25C16284748780-11030e365-66f4-111a-e063-dadaa90a10e2ASTONEA GREEN PAIN GEL
77338-015-632024-01-30C16284748780-11030e365-66f4-111a-e063-dadaa90a10e2ASTONEA GREEN PAIN GEL
77338-015-652024-01-30C16284748780-11030e365-66f4-111a-e063-dadaa90a10e2ASTONEA GREEN PAIN GEL
77338-015-672024-01-30C16284748780-11030e365-66f4-111a-e063-dadaa90a10e2ASTONEA GREEN PAIN GEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77338-015-63ASTONEA GREEN gel2.9 g in 1 POUCHGEL2.93
77338-015-65ASTONEA GREEN gel113 g in 1 TUBEGEL1133
77338-015-67ASTONEA GREEN gel907 g in 1 BOTTLE, DISPENSINGGEL9073

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77338-015ASTONEA GREEN GEL (MENTHOL) GEL [ASTONEA LABS PRIVATE LIMITED]3Legacy NDC, 3 package rows20240627_e69c2450-d16a-d5dc-e053-2995a90ab34d.zip

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
77338-01577338-015-65, 77338-015-67, 77338-015-63

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
FD&C BLUE NO. 1H3R47K3TBDIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
FD&C YELLOW NO. 5I753WB2F1MIACT
ALOE VERA LEAFZY81Z83H0XIACT
ARCTIUM LAPPA ROOT597E9BI3Z3IACT
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
CARBOXYPOLYMETHYLENE0A5MM307FCIACT
GLYCERINPDC6A3C0OXIACT
ISOPROPYL ALCOHOLND2M416302IACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
.ALPHA.-TOCOPHEROLH4N855PNZ1IACT
TROLAMINE9O3K93S3TKIACT
WATER059QF0KO0RIACT
MENTHOLL7T10EIP3AACTIB

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
1bbaaf3a-acf9-f6a8-e063-6394a90afabbe69c2450-d16a-d5dc-e053-2995a90ab34d2024-06-25WarningsExact identifier
spl id: 1bbaaf3a-acf9-f6a8-e063-6394a90afabb
spl set id: e69c2450-d16a-d5dc-e053-2995a90ab34d

Reported adverse events (FAERS/openFDA)#

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