Artrex Cream
FDA Label NDC 68354-131

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Bioved Pharmaceuticals for the product Artrex (NDC 68354-131). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, otc - keep out of reach of children, indications & usage, warnings, inactive ingredient, dosage & administration, artrex 60g tube, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient



Active Ingredients:                                                        

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

Otc - Purpose


Topical Analgesic






Otc - 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

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