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  5. Label Information: Icequake Coldn Hot Medicated Patch

FDA Label for Icequake Coldn Hot Medicated Patch

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. DO NOT USE
    8. STOP USE AND ASK A DOCTOR IF
    9. IF PREGNANT OR BREAST-FEEDING,
    10. KEEP OUT OF REACH OF CHILDREN.
    11. DIRECTIONS
    12. OTHER INFORMATION
    13. INACTIVE INGREDIENTS
    14. PACKAGE LABELING:

Icequake Coldn Hot Medicated Patch 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 sprains • 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 conctact 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:store at room temperature


Other Information



store at room temperature


Inactive Ingredients



CARBOXYMETHYLCELLULOSE, DIHYDROXYALUMINUM AMINOACETATE, GLYCERIN, KAOLIN, METHYLPARABEN, MINERAL OIL, PETROLATUM, POLYACRYLIC ACID , PROPYLENE GLYCOL, POLYSORBATE 80, POVIDONE, PROPYLPARABEN, SODIUM POLYACRYLATE, TARTARIC ACID, TITANIUM DIOXIDE, WATER


Package Labeling:



RL1 - RevisedLabel

RL1 - RevisedLabel


* Please review the disclaimer below.