Composition

Composition
SPL v18
SPL
SPL Set ID f1c77900-b2c2-4c27-8ac8-e211b7d080ad
Route
TOPICAL
Published
Effective Date 2014-01-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Camphor (natural) (3 g) Menthol (1.8 g) Turpentine (6 g)
Inactive Ingredients
Methyl Salicylate Eucalyptus Oil West Indian Lemongrass Oil Cinnamon Oil Rose Oil Ginger Oil Thymol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2004-04-01

Description

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


Medication Information

Warnings and Precautions


  • 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

Indications and Usage

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

and sports injuries

Dosage and Administration

Adults and children 6 years of age and older

Apply to affected area 3-4 times a day

Description

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

Section 50565-1



KEEP OUT OF REACH OF CHILDREN

Section 51727-6

Other Ingredients

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

Rose Oil, Thymol, Cream Base

Section 55105-1



Topical Analgesic











Section 55106-9





Active Ingredients:                                                        

Camphora Officinarum (Camphor)    5 %                      

Mentha Piperita (Menthol)                3 %                      

Pinus Longifolia(Turpentine Oil)        10 %                    

Artrex 60g Tube

Artrex Tube


Structured Label Content

Indications and Usage (34067-9)

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

and sports injuries

Dosage and Administration (34068-7)

Adults and children 6 years of age and older

Apply to affected area 3-4 times a day

Warnings and Precautions (34071-1)


  • 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

Section 50565-1 (50565-1)



KEEP OUT OF REACH OF CHILDREN

Section 51727-6 (51727-6)

Other Ingredients

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

Rose Oil, Thymol, Cream Base

Section 55105-1 (55105-1)



Topical Analgesic











Section 55106-9 (55106-9)





Active Ingredients:                                                        

Camphora Officinarum (Camphor)    5 %                      

Mentha Piperita (Menthol)                3 %                      

Pinus Longifolia(Turpentine Oil)        10 %                    

Artrex 60g Tube

Artrex Tube


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)