ARHTRI PLUS  - menthol,eucalyptus oil,clove oil spray 
Distributions Ar?mes d`Espagne Enr

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active Ingredients

Menthol 2.5%

Encalyptus oil (Eucalyptus globutus) (leaf) 0.72%

Clove Oil (Eugenia caryophyllatus) (leaf) 0.25%


Purpose

Topical Analgesic


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.


Warnings

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.


Directions

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

Camphor, Isopropyl Alcohol, Peppermint Oil, Purified Water


Other Information

Do not use if seal is broken.


Questions or comments?

1-888-331-3911 or www.fastactingpainrelief.com


Principal Display Panel

Made in Canada

+Arthri-Plus

Vaporisateur / Spray

NPN 80009727

Net Wt. 150 ml.


Label




ARHTRI PLUS  
menthol,eucalyptus oil,clove oil spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69320-100
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL2.5 g  in 100 g
EUCALYPTUS OIL (UNII: 2R04ONI662) (EUCALYPTUS OIL - UNII:2R04ONI662) EUCALYPTUS OIL0.72 g  in 100 g
CLOVE OIL (UNII: 578389D6D0) (CLOVE OIL - UNII:578389D6D0) CLOVE OIL0.25 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69320-100-01150 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product10/30/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34810/30/2014
Labeler - Distributions Ar?mes d`Espagne Enr (241070528)
Establishment
NameAddressID/FEIBusiness Operations
Distributions Ar?mes d`Espagne Enr241070528manufacture(69320-100)

Revised: 9/2016
Document Id: b50a1e42-2df7-4082-bfea-cbe7a2d6538e
Set id: da7808fa-a95e-4369-b6ac-c22a46c07291
Version: 2
Effective Time: 20160914
 
Distributions Ar?mes d`Espagne Enr