Label: ARHTRI PLUS- menthol,eucalyptus oil,clove oil spray

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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.

Drug Label Information

Updated September 14, 2016

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  • 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




  • INGREDIENTS AND APPEARANCE
    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)
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