Label: ARTHRONEO- camphor 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 October 27, 2021

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  • Active Ingredient

    Camphor 0.50%

  • Purpose

    External Analgesic

  • Uses

    For temporary relief of pain

  • Warnings

    For external use only.

  • Do Not use

    In large quantities, particularly over raw surfaces or blistered areas.• If condition worsens or if symptoms persist for more than 7 days or clear up and ocur again within a few days, discontinue use of this product and consult a doctor.

  • When Using This Product

    Avoid contact with the eyes

  • Stop using and Ask a Doctor

    if irritation or rash occurs.

  • Keep Out Of Reach of Children

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily. Children under 2 years of age:
    consult a doctor.

  • Other Information

    Keep dry. Store at 5'C and 20'C.

  • Inactive Ingredients

    Sensil CH SP, Amica montana flower extract, Benzyl alcohol, Citric acid, Disodium EDTA, Limonene, Lavandula angustifolia herb oil,
    Linalool, Peg-40 hydrogenated castor oil, Potassium sorbate, Propylene glycol, Sodium benzoate, Water

  • Principal Display

    Made in the EU

    Manufacturered for Likasso, LTD

    Grafenberger Alle 115

    4023 Dusseldorf, Germany

    NDC: 82225-001-50

    LABEL

    BOX

  • INGREDIENTS AND APPEARANCE
    ARTHRONEO 
    camphor spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82225-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL)0.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    LAVANDULA ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)  
    LINALOOL, (+)- (UNII: F4VNO44C09)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    WATER (UNII: 059QF0KO0R)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    PEG-40 CASTOR OIL (UNII: 4ERD2076EF)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82225-001-501 in 1 BOX10/27/2021
    150 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34810/27/2021
    Labeler - Hakimian Global LLC (117010019)
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