ARTREX- camphor, menthol, and turpentine cream

ARTREX by

Drug Labeling and Warnings

ARTREX by is a Otc medication manufactured, distributed, or labeled by Bioved Pharmaceuticals, Bioved Pharmaceuticals Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

ARTREX 
camphor, menthol, and turpentine cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68354-131
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941)	CAMPHOR (NATURAL)	3 g  in 60 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	1.8 g  in 60 g
TURPENTINE (UNII: XJ6RUH0O4G) (TURPENTINE - UNII:XJ6RUH0O4G)	TURPENTINE	6 g  in 60 g

Inactive Ingredients
Ingredient Name	Strength
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
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68354-131-60	60 g in 1 TUBE; Type 0: Not a Combination Product	07/01/2014
2	NDC: 68354-131-10	10 g in 1 TUBE; Type 0: Not a Combination Product	08/02/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	04/01/2004

Labeler - Bioved Pharmaceuticals (131537917)

Establishment
Name	Address	ID/FEI	Business Operations
Bioved Pharmaceuticals		131537917	manufacture(68354-131)

Establishment
Name	Address	ID/FEI	Business Operations
Bioved Pharmacuticals Pvt. Ltd.		859096834	manufacture(68354-131)

Establishment
Name	Address	ID/FEI	Business Operations
Kremoint Pharma		918325986	manufacture(68354-131)