Label: ARTREX- camphor, menthol, and turpentine cream

  • NDC Code(s): 68354-131-10, 68354-131-60
  • Packager: Bioved Pharmaceuticals
  • 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 30, 2023

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  • ACTIVE INGREDIENT



    Active Ingredients:                                                        

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

  • PURPOSE


    Topical Analgesic






  • KEEP OUT OF REACH OF CHILDREN


    KEEP OUT OF REACH OF CHILDREN

  • INDICATIONS & USAGE

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

  • WARNINGS


    • 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

    Other Ingredients

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

    Rose Oil, Thymol, Cream Base

  • DOSAGE & ADMINISTRATION

    Adults and children 6 years of age and older

    Apply to affected area 3-4 times a day

  • Artrex 60g Tube

    Artrex Tube Artrex-60g Tube

  • INGREDIENTS AND APPEARANCE
    ARTREX 
    camphor, menthol, and turpentine cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68354-131
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL)3 g  in 60 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1.8 g  in 60 g
    TURPENTINE (UNII: XJ6RUH0O4G) (TURPENTINE - UNII:XJ6RUH0O4G) TURPENTINE6 g  in 60 g
    Inactive Ingredients
    Ingredient NameStrength
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    WEST INDIAN LEMONGRASS OIL (UNII: 5BIA40E9ED)  
    CINNAMON OIL (UNII: E5GY4I6YCZ)  
    ROSE OIL (UNII: WUB68Y35M7)  
    GINGER OIL (UNII: SAS9Z1SVUK)  
    THYMOL (UNII: 3J50XA376E)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68354-131-6060 g in 1 TUBE; Type 0: Not a Combination Product07/01/2014
    2NDC:68354-131-1010 g in 1 TUBE; Type 0: Not a Combination Product08/02/2017
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34804/01/2004
    Labeler - Bioved Pharmaceuticals (131537917)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bioved Pharmaceuticals Inc.131537917manufacture(68354-131)
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