1. Home
  2. Labeler Index
  3. Rising Pharma Holdings, Inc.
  4. 57237-351
  5. Label Information: Coolexa

FDA Label for Coolexa

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. OTC - PURPOSE
    3. USES
    4. WARNINGS
    5. DO NOT USE
    6. OTC - ASK DOCTOR
    7. WHEN USING THIS PRODUCT
    8. STOP USE AND ASK A DOCTOR IF
    9. OTC - KEEP OUT OF REACH OF CHILDREN
    10. DIRECTIONS
    11. OTHER INFORMATION
    12. INACTIVE INGREDIENTS
    13. QUESTIONS AND COMMENTS?
    14. PRINCIPAL DISPLAY PANEL - 113 G TUBE CARTON

Coolexa Product Label

The following document was submitted to the FDA by the labeler of this product Rising Pharma Holdings, Inc.. 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.

Other



Drug Facts

CoolexaTM is a trademark owned by Rising Pharma Holdings, Inc.

Distributed by:
Rising Pharma Holdings, Inc.
East Brunswick, NJ 08816
Made in India
Mfg. Lic. No.: G/25/1362


Otc - Purpose



Active IngredientsPurpose
Camphor 4%Topical analgesic
Menthol 10%Topical analgesic
Methyl Salicylate 30%Topical analgesic


Uses



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

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains

Warnings



For external use only.


Do Not Use



  • on wounds or damaged skin
  • with a heating pad or apply external heat
  • on a child under 12 years of age with arthritis-like conditions

Otc - Ask Doctor



Ask a doctor before use if you have redness over the affected area


When Using This Product



  • avoid contact with eyes or mucous membranes
  • do not bandage tightly

Stop Use And Ask A Doctor If



  • condition worsens or symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days
  • excessive skin irritation occurs

Otc - Keep Out Of Reach Of Children



Keep out of reach of children.

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


Directions



  • use only as directed
  • adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily
  • children under 12 years of age: ask a doctor

Other Information



  • store at 20° to 25°C (68° to 77°F)
  • Lot No. & Exp Date: See box or crimp of tube

Inactive Ingredients



Carbomer, disodium edetate, glyceryl stearate SE, lanolin, polysorbate 80, potassium hydroxide, stearic acid, trolamine, water.


Questions And Comments?



Call 1-844-474-7464


* Please review the disclaimer below.