ARTREX- camphor, menthol, and turpentine cream 
Bioved Pharmaceuticals

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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Composition



Active Ingredients:                                                        

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


Topical Analgesic







KEEP OUT OF REACH OF CHILDREN

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


Other Ingredients

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

Rose Oil, Thymol, Cream Base

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

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)

Revised: 9/2023
Document Id: 069728be-5884-9de6-e063-6394a90afc4b
Set id: f1c77900-b2c2-4c27-8ac8-e211b7d080ad
Version: 15
Effective Time: 20230930
 
Bioved Pharmaceuticals