1. Home
  2. Labeler Index
  3. Chattem, Inc.
  4. 41167-0843
  5. Label Information: Icy Hot Back And Large Areas

FDA Label for Icy Hot Back And Large Areas

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. IF PREGNANT OR BREAST-FEEDING
    8. KEEP OUT OF REACH OF CHILDREN.
    9. DIRECTIONS
    10. INACTIVE INGREDIENTS
    11. PRINCIPAL DISPLAY PANEL

Icy Hot Back And Large Areas Product Label

The following document was submitted to the FDA by the labeler of this product Chattem, 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.

Active Ingredient



Menthol 5%

Menthol 5%

Menthol 5%


Purpose



Topical analgesic

Topical analgesic

Topical analgesic


Uses



  • temporarily relieves minor pain associated with:
    • arthritis
    • simple backache
    • bursitis
    • tendonitis
    • muscle strains
    • sprains
    • bruises
    • cramps
      • temporarily relieves minor pain associated with:
        • arthritis
        • simple backache
        • bursitis
        • tendonitis
        • muscle strains
        • sprains
        • bruises
        • cramps
          • temporarily relieves minor pain associated with:
            • arthritis
            • simple backache
            • bursitis
            • tendonitis
            • muscle strains
            • sprains
            • bruises
            • cramps

Warnings



For external use only

For external use only

For external use only


When Using This Product



  • use only as directed
  • do not bandage tightly or use with a heating pad
  • avoid contact with eyes and mucous membranes
  • do not apply to wounds or damaged skin, broken or irritated skin 
    • use only as directed
    • do not bandage tightly or use with a heating pad
    • avoid contact with eyes and mucous membranes
    • do not apply to wounds or damaged skin 
      • use only as directed
      • do not bandage tightly or use with a heating pad
      • avoid contact with eyes and mucous membranes
      • do not apply to wounds or damaged skin, broken or irritated skin 

Stop Use And Ask A Doctor If



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

If Pregnant Or Breast-Feeding



ask a health professional before use.

ask a health professional before use.

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.

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

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


Directions



adults and children over 12 years.

  • remove backing from patch by grasping both ends firmly and gently pulling until backing separates in middle
  • carefully remove smaller portion of backing from patch and apply exposed portion of patch to affected area
  • once exposed portion of patch is positioned, carefully remove remaining backing to completely apply patch to affected area
  • apply one patch to affected area
  • wear one Icy Hot Patch up to 8 hours
  • repeat as necessary, but no more than 4 times daily

    • children 12 years or younger: ask a doctor

    adults and children over 12 years.

    • remove backing from patch by grasping both ends firmly and gently pulling until backing separates in middle
    • carefully remove backing from patch
    • apply one patch to affected area
    • wear one Icy Hot Patch up to 8 hours
    • repeat as necessary, but no more than 4 times daily

      • children 12 years or younger: ask a doctor

      adults and children over 12 years.

      • remove backing from patch by grasping both ends firmly and gently pulling until backing separates
      • carefully remove smaller portion of backing from patch and apply exposed portion of patch to affected area
      • once exposed portion of patch is positioned, carefully remove remaining backing to completely apply patch to affected area
      • apply one patch to affected area
      • wear one Icy Hot Patch up to 8 hours
      • repeat as necessary, but no more than 4 times daily

        • children 12 years or younger: ask a doctor


Inactive Ingredients



acrylic acid, aluminum hydroxide, carmellose sodium, 2-ethylhexyl acrylate, glycerin, isopropyl myristate, methyl acrylate, nonoxynol-30, polyacrylate, polyacrylic acid, polysorbate 80, sorbitan sesquioleate, starch, talc, tartaric acid, titanium dioxide, water 

KEEP CARTON AS IT CONTAINS IMPORTANT INFORMATION FOR USAGE OF THE PRODUCT.

Distributed by Chattem, Inc.
P.O. Box 2219
Chattanooga, TN 37409-0219 USA 
©2007 www.icyhot.com  
Made in Japan.   0049602-01




Icy Hot® - Medicated Patch

BACK & LARGE AREAS

acrylic acid, aluminum hydroxide, carmellose sodium, 2-ethylhexyl acrylate, glycerin, isopropyl myristate, methyl acrylate, nonoxynol-30, polyacrylate, polyacrylic acid, polysorbate 80, sorbitan sesquioleate, starch, talc, tartaric acid, titanium dioxide, water 

Visit us on the web at www.icyhot.com Made in Japan



Icy Hot® - Medicated Patch

XL BACK & LARGE AREAS

acrylic acid, aluminum hydroxide, carmellose sodium, 2-ethylhexyl acrylate, glycerin, isopropyl myristate, methyl acrylate, nonoxynol-30, polyacrylate, polyacrylic acid, polysorbate 80, sorbitan sesquioleate, starch, talc, tartaric acid, titanium dioxide, water

KEEP CARTON AS IT CONTAINS IMPORTANT INFORMATION FOR USAGE OF THE PRODUCT.

Made in Japan. Visit us on the web at www.icyhot.com 0044855-02




Principal Display Panel



EXTRA STRENGTH
ICY HOT®  
MEDICATED PATCH
Menthol 5%
ICY to DULL the PAIN – HOT to RELAX it away®
Lasts up to 8 Hours!
Small Patch
3-1/8” x 4-5/8” (8 cm x 12 cm) each
Pain Relieving Ointment on
a Breathable Adhesive Pad
ARM. NECK & LEG
& SMALL AREAS
Contains 5 Patches in 1 Resealable Pouch

Principal Display Panel - icy hot patch 01

Principal Display Panel - icy hot patch 01

EXTRA STRENGTH
ICY HOT®  
MEDICATED PATCH
Menthol 5%
ICY to DULL the PAIN – HOT to RELAX it away®
Lasts up to 8 Hours!
LARGE PATCH
3-15/16” x 7-13/16” (10 cm x 20 cm) each
Pain Relieving Ointment on
a Breathable Adhesive Pad
BACK
& LARGE AREAS
Contains 5 Patches
In 1 Resealable Pouch

EXTRA STRENGTH
ICY HOT®  
MEDICATED PATCH XL
Menthol 5%
ICY to DULL the PAIN – HOT to RELAX it away®
75 % Larger
Than Regular Back Patches
Lasts up to 8 Hours!
EXTRA LARGE PATCH
5-1/2” x 9-3/4” (14 cm x 25 cm) each
Pain Relieving Ointment on
a Breathable Adhesive Pad
XL BACK
& LARGE AREAS
Contains 3 Patches
In 1 Resealable Pouch

  


* Please review the disclaimer below.