FDA.reportPublic FDA data

Arhtri Plus

Manufacturer
Distributions Ar?mes d`Espagne Enr
Effective date
2016-09-14
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:47:07

Label at a glance#

ProductArhtri Plus
Active ingredientMENTHOL, EUCALYPTUS OIL, CLOVE OIL
Label structure9 sections

Indications and uses

For the temporary relief of aches and pains of muscles and joints associated with backache, lumbago,strains, bruises,sprains and arthritic or rheumatic pain, pain of tendons and ligaments.

Dosage and administration

For adults and children 2 years of age and older: Shake well before use. Apply to the affected area not more than 3-4 times daily. Allow absorption to occur naturally for maximum penetration. If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a health care practitioner.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Menthol 2.5%

Encalyptus oil (Eucalyptus globutus) (leaf) 0.72%

Clove Oil (Eugenia caryophyllatus) (leaf) 0.25%


Purpose

OTC - PURPOSE SECTION

Topical Analgesic


Uses

INDICATIONS & USAGE SECTION

For the temporary relief of aches and pains of muscles and joints associated with backache, lumbago,strains, bruises,sprains and arthritic or rheumatic pain, pain of tendons and ligaments.


Warnings

WARNINGS SECTION

For external use only. Do not apply to wounds or damaged skin. Do not inhale. Avoid contact with eyes and mucous membranes. Discontinue use if rash or irritation occurs. The application of external heat, such as an electric heating pad, may result in excessive skin irritation or skin burn. Do not bandage. Keep away from heat, sparks and open flames.


Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION


Directions

DOSAGE & ADMINISTRATION SECTION

For adults and children 2 years of age and older: Shake well before use. Apply to the affected area not more than 3-4 times daily. Allow absorption to occur naturally for maximum penetration. If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a health care practitioner.


Inactive Ingredients

INACTIVE INGREDIENT SECTION

Camphor, Isopropyl Alcohol, Peppermint Oil, Purified Water


Other Information

SPL UNCLASSIFIED SECTION

Do not use if seal is broken.


Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Made in Canada

+Arthri-Plus

Vaporisateur / Spray

NPN 80009727

Net Wt. 150 ml.


LabelLabel




DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1592734menthol 2.5 % / eucalyptus oil 0.72 % / clove oil 0.25 % Topical SprayPSN2
1592734clove oil 2.5 MG/ML / Eucalyptus oil 7.2 MG/ML / menthol 25 MG/ML Topical SpraySCD2
1592734clove oil 0.25 % / eucalyptus oil 0.72 % / menthol 2.5 % Topical SpraySY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69320-100-012020-01-31C16284748780-19d75b9d0-a558-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69320-100-01Arhtri Plus150 g in 1 BOTTLE, SPRAYSPRAY1502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69320-100ARHTRI PLUS (MENTHOL,EUCALYPTUS OIL,CLOVE OIL) SPRAY [DISTRIBUTIONS AR?MES D`ESPAGNE ENR]2Legacy NDC, 1 package rows20160916_da7808fa-a95e-4369-b6ac-c22a46c07291.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CLOVE OILACTIVE INGREDIENT578389D6D01
EUCALYPTUS OILACTIVE INGREDIENT2R04ONI6621
MENTHOLACTIVE INGREDIENTL7T10EIP3A1
CLOVE OILACTIVE MOIETY578389D6D01
EUCALYPTUS OILACTIVE MOIETY2R04ONI6621
MENTHOLACTIVE MOIETYL7T10EIP3A1
CAMPHOR (SYNTHETIC)INACTIVE INGREDIENT5TJD82A1ET1
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M4163021
PEPPERMINT OILINACTIVE INGREDIENTAV092KU4JH1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69320-10069320-100-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
CAMPHOR (SYNTHETIC)5TJD82A1ETIACT
ISOPROPYL ALCOHOLND2M416302IACT
PEPPERMINT OILAV092KU4JHIACT
WATER059QF0KO0RIACT
MENTHOLL7T10EIP3AACTIB
EUCALYPTUS OIL2R04ONI662ACTIB
CLOVE OIL578389D6D0ACTIB

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 · 32 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
PEPPERMINT OILPEPPERMINT OILAV092KU4JHSUSPENSION / ORAL100 mg/1mlExact identifier — unii candidate
21 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302TABLET, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
9 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHSOLUTION / ORAL53 mgExact identifier — unii candidate
21 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHSOLUTION / DENTAL0.04 %v/vExact identifier — unii candidate
21 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHPOWDER, DENTIFRICE / DENTALNAExact identifier — unii candidate
21 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302LOTION, AUGMENTED / TOPICAL2070 mgExact identifier — unii candidate
9 equally ranked IID candidates
CAMPHOR (SYNTHETIC)CAMPHOR (SYNTHETIC)5TJD82A1ETDROPS / OPHTHALMICNAExact identifier — unii candidate
2 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHELIXIR / ORAL0.04 mg/1mlExact identifier — unii candidate
21 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHGUM, CHEWING / BUCCAL526 mgExact identifier — unii candidate
21 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302OIL / TOPICAL72 mgExact identifier — unii candidate
9 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHFILM, SOLUBLE / BUCCAL3 mgExact identifier — unii candidate
21 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHSYRUP / ORAL120 mgExact identifier — unii candidate
21 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHPOWDER / SUBLINGUAL1 mgExact identifier — unii candidate
21 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHOINTMENT / TOPICAL0.2 %w/wExact identifier — unii candidate
21 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHSPRAY, METERED / SUBLINGUAL1 mgExact identifier — unii candidate
21 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHFILM / BUCCAL12 mgExact identifier — unii candidate
21 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHCAPSULE / ORAL60 mgExact identifier — unii candidate
21 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302OIL / AURICULAR (OTIC)6 mgExact identifier — unii candidate
9 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHLOZENGE / ORAL12 mgExact identifier — unii candidate
21 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302SOLUTION / TOPICAL40 %w/vExact identifier — unii candidate
9 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302GEL, METERED / TOPICAL525 mgExact identifier — unii candidate
9 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHTABLET / SUBLINGUAL0.15 mgExact identifier — unii candidate
21 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302SWAB / TOPICAL43.9 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
CAMPHOR (SYNTHETIC)CAMPHOR (SYNTHETIC)5TJD82A1ETJELLY / NASAL65 mgExact identifier — unii candidate
2 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHPASTE, DENTIFRICE / DENTAL49.3 %w/wExact identifier — unii candidate
21 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHTABLET / ORAL28 mgExact identifier — unii candidate
21 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302SPONGE / TOPICAL4 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHSHAMPOO / TOPICAL0.2 %w/wExact identifier — unii candidate
21 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302GEL / TOPICAL75 mgExact identifier — unii candidate
9 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHTABLET, ORALLY DISINTEGRATING / ORAL3 mgExact identifier — unii candidate
21 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHCONCENTRATE / ORAL0.05 mgExact identifier — unii candidate
21 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHGUM, CHEWING / ORAL526 mgExact identifier — unii candidate
21 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
b50a1e42-2df7-4082-bfea-cbe7a2d6538eda7808fa-a95e-4369-b6ac-c22a46c072912016-09-14WarningsExact identifier
spl id: b50a1e42-2df7-4082-bfea-cbe7a2d6538e
spl set id: da7808fa-a95e-4369-b6ac-c22a46c07291

Reported adverse events (FAERS/openFDA)#

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