FDA.reportPublic FDA data

ARTREX

Manufacturer
Bioved Pharmaceuticals | UNIJULES LIFE SCIENCES LIMITED
Effective date
2025-04-10
Label type
HUMAN OTC DRUG LABEL
Version
18
Source
full-release
Hydrated at
2026-06-01 00:59:00

Label at a glance#

ProductARTREX
Active ingredientCAMPHOR (NATURAL), MENTHOL, TURPENTINE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION



Active Ingredients:                                                        

Camphora Officinarum (Camphor)    5 %                      
Mentha Piperita (Menthol)                3 %                      
Pinus Longifolia(Turpentine Oil)        10 %                    

OTC - PURPOSE SECTION


Topical Analgesic

OTC - KEEP OUT OF REACH OF CHILDREN SECTION


KEEP OUT OF REACH OF CHILDREN

INDICATIONS & USAGE SECTION

Temporarily relieves aches and pains of muscles and joints due to arthritis, simple backache, sprains, strains,
and sports injuries

WARNINGS SECTION


  • Do not apply to wound or damaged skin
  • Do not bandage tightly
  • Do not swallow. If swallowed call a physician or contact a poison control center immediately
  • Keep away from eyes, mucous membranes, broken or irritated skin
  • If skin redness or irritation develops or pain lasts more than 10 days, discontinue use and call a physician

INACTIVE INGREDIENT SECTION

Other Ingredients

Cinnamon Oil, Eucalyptus Oil, Ginger Oil, Lemon Grass Oil, Oil of Wintergreen,

Rose Oil, Thymol, Cream Base

DOSAGE & ADMINISTRATION SECTION

Adults and children 6 years of age and older

Apply to affected area 3-4 times a day

Artrex 60g Tube

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Artrex Tube Artrex-60g TubeArtrex-60g Tube

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1551280camphor 5 % / menthol 3 % / turpentine oil 10 % Topical CreamPSN18
1551280camphor 50 MG/ML / menthol 30 MG/ML / turpentine 100 MG/ML Topical CreamSCD18
1551280camphor 5 % / menthol 3 % / turpentine 10 % Topical CreamSY18
1551280camphor 5 % / menthol 3 % / turpentine oil 10 % Topical CreamSY18

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68354-131-102024-01-30C16284748780-1c7ccaba7-207f-fd44-e053-dadaa90aa01bComposition
68354-131-602024-01-30C16284748780-1c7ccaba7-207f-fd44-e053-dadaa90aa01bComposition
68354-131-102021-08-17C16284748780-1c7ccaba7-207f-fd44-e053-dadaa90aa01bComposition
68354-131-602021-08-17C16284748780-1c7ccaba7-207f-fd44-e053-dadaa90aa01bComposition
68354-131-102021-07-23C16284748780-1c7ccaba7-207f-fd44-e053-dadaa90aa01bComposition
68354-131-602021-07-23C16284748780-1c7ccaba7-207f-fd44-e053-dadaa90aa01bComposition

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68354-131-10ARTREX10 g in 1 TUBECREAM1018
68354-131-60ARTREX60 g in 1 TUBECREAM6018

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68354-131ARTREX (CAMPHOR, MENTHOL, AND TURPENTINE) CREAM [BIOVED PHARMACEUTICALS]18Legacy NDC, 2 package rows20250412_f1c77900-b2c2-4c27-8ac8-e211b7d080ad.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CAMPHOR (NATURAL)ACTIVE INGREDIENTN20HL7Q9413
MENTHOLACTIVE INGREDIENTL7T10EIP3A3
TURPENTINEACTIVE INGREDIENTXJ6RUH0O4G3
CAMPHOR (NATURAL)ACTIVE MOIETYN20HL7Q9413
MENTHOLACTIVE MOIETYL7T10EIP3A3
TURPENTINEACTIVE MOIETYXJ6RUH0O4G3
CINNAMON OILINACTIVE INGREDIENTE5GY4I6YCZ3
EUCALYPTUS OILINACTIVE INGREDIENT2R04ONI6623
GINGER OILINACTIVE INGREDIENTSAS9Z1SVUK3
METHYL SALICYLATEINACTIVE INGREDIENTLAV5U5022Y3
ROSE OILINACTIVE INGREDIENTWUB68Y35M73
THYMOLINACTIVE INGREDIENT3J50XA376E3
WEST INDIAN LEMONGRASS OILINACTIVE INGREDIENT5BIA40E9ED3

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68354-13168354-131-60, 68354-131-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
METHYL SALICYLATELAV5U5022YIACT
EUCALYPTUS OIL2R04ONI662IACT
WEST INDIAN LEMONGRASS OIL5BIA40E9EDIACT
CINNAMON OILE5GY4I6YCZIACT
ROSE OILWUB68Y35M7IACT
GINGER OILSAS9Z1SVUKIACT
THYMOL3J50XA376EIACT
CAMPHOR (NATURAL)N20HL7Q941ACTIB
MENTHOLL7T10EIP3AACTIB
TURPENTINEXJ6RUH0O4GACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 17 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
CINNAMON OILCINNAMON OILE5GY4I6YCZPASTE, DENTIFRICE / DENTALNAExact identifier — unii candidate
6 equally ranked IID candidates
THYMOLTHYMOL3J50XA376ELIQUID / RESPIRATORY (INHALATION)0.01 %w/wExact identifier — unii candidate
2 equally ranked IID candidates
METHYL SALICYLATEMETHYL SALICYLATELAV5U5022YPOWDER / TOPICALNAExact identifier — unii candidate
8 equally ranked IID candidates
EUCALYPTUS OILEUCALYPTUS OIL2R04ONI662SYRUP / ORALNAExact identifier — unii candidate
METHYL SALICYLATEMETHYL SALICYLATELAV5U5022YDOUCHE / VAGINAL0.05 %w/wExact identifier — unii candidate
8 equally ranked IID candidates
CINNAMON OILCINNAMON OILE5GY4I6YCZSUSPENSION / ORAL0.2 mg/5mlExact identifier — unii candidate
6 equally ranked IID candidates
CINNAMON OILCINNAMON OILE5GY4I6YCZELIXIR / ORAL0.58 mg/5mlExact identifier — unii candidate
6 equally ranked IID candidates
METHYL SALICYLATEMETHYL SALICYLATELAV5U5022YPOWDER, DENTIFRICE / DENTALNAExact identifier — unii candidate
8 equally ranked IID candidates
METHYL SALICYLATEMETHYL SALICYLATELAV5U5022YPASTE, DENTIFRICE / DENTAL1.1 %w/wExact identifier — unii candidate
8 equally ranked IID candidates
CINNAMON OILCINNAMON OILE5GY4I6YCZPASTILLE / ORAL4 mgExact identifier — unii candidate
6 equally ranked IID candidates
CINNAMON OILCINNAMON OILE5GY4I6YCZPOWDER, DENTIFRICE / DENTALNAExact identifier — unii candidate
6 equally ranked IID candidates
METHYL SALICYLATEMETHYL SALICYLATELAV5U5022YGEL / TOPICAL0.05 %w/wExact identifier — unii candidate
8 equally ranked IID candidates
THYMOLTHYMOL3J50XA376EPOWDER, FOR SOLUTION / ORALNAExact identifier — unii candidate
2 equally ranked IID candidates
METHYL SALICYLATEMETHYL SALICYLATELAV5U5022YCAPSULE / ORAL16 mgExact identifier — unii candidate
8 equally ranked IID candidates
METHYL SALICYLATEMETHYL SALICYLATELAV5U5022YLOZENGE / ORAL53 mgExact identifier — unii candidate
8 equally ranked IID candidates
METHYL SALICYLATEMETHYL SALICYLATELAV5U5022YTABLET / ORAL10 mgExact identifier — unii candidate
8 equally ranked IID candidates
CINNAMON OILCINNAMON OILE5GY4I6YCZSYRUP / ORAL0.05 mg/5mlExact identifier — unii candidate
6 equally ranked IID candidates

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
3274fbeb-5bb7-fc45-e063-6294a90a0586f1c77900-b2c2-4c27-8ac8-e211b7d080ad2025-04-10WarningsExact identifier
spl id: 3274fbeb-5bb7-fc45-e063-6294a90a0586
spl set id: f1c77900-b2c2-4c27-8ac8-e211b7d080ad

Reported adverse events (FAERS/openFDA)#

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