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  5. Label Information: Orthogel Menthol 3.5% Roll On

FDA Label for Orthogel Menthol 3.5% Roll On

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. WHEN USING THIS PRODUCT:
    6. STOP USE AND ASK A DOCTOR IF
    7. KEEP OUT OF REACH OF CHILDREN.
    8. DIRECTIONS
    9. OTHER INFORMATION
    10. INACTIVE INGREDIENTS

Orthogel Menthol 3.5% Roll On Product Label

The following document was submitted to the FDA by the labeler of this product Liquidcapsule Manufacturing Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredient



Menthol 3.5%


Purpose



Pain Relieving Gel


Uses



Temporarily relieves minor aches and pains of muscles and joints associated with:

  • simple backache 
  • arthritis 
  • strains
  • bruises 
  • sprains

Warnings



For external use only.

Flammable: Keep away from excessive heat or open flame


When Using This Product:



  • use only as directed
  • avoid contact with the eyes or on mucous membranes
  • do not apply to wounds or damaged skin
  • do not apply to irritated skin or if excessive irritation develops
  • do not bandage tightly or use with heating pad or device

Stop Use And Ask A Doctor If



  • you experience pain, swelling or blistering of the skin
  • condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days
  • arthritic pain persists for more than 10 days, or redness is present or in conditions affecting children under 12 years of age

Keep Out Of Reach Of Children.



 If swallowed, get medical help or contact a Poison Control Center right away.


Directions



  • adults and children 12 years of age and older: rub a thin film over affected area not more than 3 to 4 times daily
  • children under 2 years of age: consult a physician
  • wash hands after use with cool water

Other Information



  • store at 20–25°C (68–77°F)
  • store in a cool dry place away from direct sunlight

Inactive Ingredients



Aloe Barbadensis Leaf Extract, Boswellia Serrata Extract (as B-NHIBITX™), Camphor, Carbomer, Dimethyl Sulfone (as OptiMSM®), FD&C Yellow #5, FD&C Blue #1, Glucosamine HCl, Ilex Paraguariensis Leaf Extract, Isopropyl Alcohol, Methylparaben, Tetrahydrodiferuloylmethane,
Tocopheryl Acetate (Vitamin E Acetate), Triethanolamine, Water.


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