FDA Label for Icy Hot Xl Back And Large Areas
View Indications, Usage & Precautions
Icy Hot Xl 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
- arthritis
- temporarily relieves minor pain associated with:
- arthritis
- simple backache
- bursitis
- tendonitis
- muscle strains
- sprains
- bruises
- cramps
- arthritis
- temporarily relieves minor pain associated with:
- arthritis
- simple backache
- bursitis
- tendonitis
- muscle strains
- sprains
- bruises
- cramps
- arthritis
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
- 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
- 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
adults and children over 12 years.
children 12 years or younger: ask a doctor
adults and children over 12 years.
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
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.