1. Home
  2. Labeler Index
  3. Mccure Health Solutions Inc.
  4. 52486-013
  5. Label Information: Ultra Strength Pain Relief Balm

FDA Label for Ultra Strength Pain Relief Balm

View Indications, Usage & Precautions

Table of Contents

    1. DRUG FACTS
    2. ACTIVE INGREDIENTS
    3. PURPOSE
    4. USES
    5. WARNINGS
    6. WHEN USING THIS PRODUCT
    7. STOP USE AND ASK A DOCTOR IF
    8. IF PREGNANT OR BREAST-FEEDING,
    9. KEEP OUT OF REACH OF CHILDREN.
    10. DIRECTIONS
    11. OTHER INFORMATION
    12. INACTIVE INGREDIENTS
    13. PRODUCT LABEL

Ultra Strength Pain Relief Balm Product Label

The following document was submitted to the FDA by the labeler of this product Mccure Health Solutions 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.

Drug Facts




Active Ingredients



Camphor 11%

Menthol 11%


Purpose



Topical analgesic


Uses



For temporary relief minors aches and pains of muscles and joints associated with over-exertion, simple backache, arthritis, strains and sprains.


Warnings



For external use only


When Using This Product



  • Avoid contact with eyes and mocous membranes
  • Do not apply to open wounds or damaged skin
  • Do not bandage or use heating pad

Stop Use And Ask A Doctor If



  • Condition worsens
  • Severe skin irritation occurs.
  • Pain persists for more than seven days
  • Pain clears up and then recurs a few days later

If Pregnant Or Breast-Feeding,



ask a healthcare professional before use


Keep Out Of Reach Of Children.



If swallowed, get medical help or contact a poison Control Center immediately.


Directions



  • Rub well on the affected area. Repeat 3 to 4 times daily

Other Information



This product may cause allergic reaction in some individuals. Test on small area before use.


Inactive Ingredients



CAJUPUT OIL, CLOVE OIL, DEMENTHOLIZED MINT OIL, PARAFFIN PETROLATUMA


* Please review the disclaimer below.