1. Home
  2. Labeler Index
  3. Southern Sales & Service, Inc.
  4. 69822-012
  5. Label Information: Icequake Coldn Hot Medicated

FDA Label for Icequake Coldn Hot Medicated

View Indications, Usage & Precautions

Table of Contents

    1. DRUG FACTS
    2. ACTIVE INGREDIENT
    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. ADULTS AND CHILDREN OVER 12 YEARS
    12. CHILDREN UNDER 12 YEARS OF AGE
    13. OTHER INFORMATION
    14. INACTIVE INGREDIENTS
    15. ICEQUAKE COLDN HOT MEDICATED PATCH 69822-010-04

Icequake Coldn Hot Medicated Product Label

The following document was submitted to the FDA by the labeler of this product Southern Sales & Service, 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 Ingredient



Menthol 5%


Purpose



Topical Analgesic


Uses



Temporarily relieves minor pain associated with:

  • arthritis
  • muscle strains
  • simple backache
  • bursitis
  • cramps
  • tendonitis
  • muscle srains
  • bruises

Warnings



For external use only


When Using This Product



  • use only as directed
  • do not bandage tightly
  • do not use a heating pad
  • avoid contact with eyes and mucous membranes
  • do not apply to wounds or damaged skin
  • do not use if you are allergic to any ingredients of this product

Stop Use And Ask A Doctor If



  • condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days
  • redness is present
  • irritation develops

If Pregnant Or Breast-Feeding,



ask a health professional before use


Keep Out Of Reach Of Children



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


Directions




Adults And Children Over 12 Years



  • Carefully remove backing film from patch
  • Apply one patch to affected area
  • Use one patch at a time, 1 or 2 times a day

Children Under 12 Years Of Age



Consult a physician


Other Information



store at room temperature


Inactive Ingredients



aluminum glycinate, castor oil, concentrate glycerin, disodium edetate hydrate, gelatin, glycol salicylate, isopropyl myristate, mentha oil, polysorbate 80, polyvinyl alcohol, polyvinylpyrrolidone, purified water, sodium polyacrylate, tataric acid, titanium oxide


* Please review the disclaimer below.