FDA.reportPublic FDA data

ASTONEA CARE Muscle and Join Pain Relief Cream

Manufacturer
ASTONEA LABS PRIVATE LIMITED
Effective date
2024-03-05
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:09:25

Label at a glance#

ProductASTONEA CARE Muscle and Join Pain Relief Cream
Active ingredientMENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE
Label structure8 sections

Indications and uses

temporarily relieves the minor aches and pains of muscles and joints associated with: simple backache arthritis strains bruises sprains

Dosage and administration

use only as directed adults and children 12 years of age and over: apply to affected area not more than 3 to 4 times daily children under 12 years of age: consult a physician.

Storage and handling

store at 20° to 25°C (68° to 77°F) do not use if tube seal under cap is broken

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Menthol 10%

Methyl salicylate 15%

OTC - PURPOSE SECTION

Active ingredientsPurpose
Menthol 10%Topical analgesic
Methyl salicylate 15%Topical analgesic

Uses

INDICATIONS & USAGE SECTION

temporarily relieves the minor aches and pains of muscles and joints associated with:

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains

Warnings

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

  • on wounds or damaged skin
  • with a heating pad
  • on a child under 12 years of age with arthritis-like conditions

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you haveredness over the affected area

When using this product

OTC - WHEN USING SECTION

  • avoid contact with eyes or mucous membranes
  • do not bandage tightly

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • excessive skin irritation occurs
  • condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions

DOSAGE & ADMINISTRATION SECTION

  • use only as directed
  • adults and children 12 years of age and over: apply to affected area not more than 3 to 4 times daily
  • children under 12 years of age: consult a physician.

Other information

STORAGE AND HANDLING SECTION

store at 20° to 25°C (68° to 77°F)

do not use if tube seal under cap is broken

Inactive ingredients

INACTIVE INGREDIENT SECTION

borax, butylated hydroxytoluene, carbopol 940, cetostearyl alcohol, cetyl alcohol, glycerol monostearate, peg 100 stearate, phenoxyethanol, sodium benzoate, stearic acid, trolamine, tween 60, water

Muscle & Joint Pain Relief Cream

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
311498menthol 10 % / methyl salicylate 15 % Topical CreamPSN1
311498menthol 100 MG/ML / methyl salicylate 150 MG/ML Topical CreamSCD1
311498menthol 10 % / methyl salicylate 15 % Topical CreamSY1
311498menthol 10 GM / methyl salicylate 15 GM per 100 GM Topical CreamSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77338-212-02ASTONEA CARE Muscle and Join Pain Relief Cream1 in 1 CARTONCREAM11
77338-212-02ASTONEA CARE Muscle and Join Pain Relief Cream56.6 g in 1 TUBECREAM56.61

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77338-212ASTONEA CARE MUSCLE AND JOIN PAIN RELIEF CREAM (MENTHOL, METHYL SALICYLATE) CREAM [ASTONEA LABS PRIVATE LIMITED]12 package rows20240307_12eeec63-cfc4-7540-e063-6394a90a65f0.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
77338-21277338-212-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
SODIUM BORATE91MBZ8H3QOIACT
CETYL ALCOHOL936JST6JCNIACT
PEG-100 STEARATEYD01N1999RIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
CARBOMER 9404Q93RCW27EIACT
TROLAMINE9O3K93S3TKIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
STEARIC ACID4ELV7Z65APIACT
WATER059QF0KO0RIACT
POLYSORBATE 60CAL22UVI4MIACT
MENTHOL, UNSPECIFIED FORML7T10EIP3AACTIB
METHYL SALICYLATELAV5U5022YACTIB

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
12eeea46-ec07-526c-e063-6294a90a96b312eeec63-cfc4-7540-e063-6394a90a65f02024-03-05WarningsExact identifier
spl id: 12eeea46-ec07-526c-e063-6294a90a96b3
spl set id: 12eeec63-cfc4-7540-e063-6394a90a65f0

Reported adverse events (FAERS/openFDA)#

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