FDA Label for Icy Hot Medicated Roll, Medium
View Indications, Usage & Precautions
Icy Hot Medicated Roll, Medium Product Label
The following document was submitted to the FDA by the labeler of this product Nichiban Company Limited. 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 7.5%
Purpose
Topical analgesic
Uses
temporarily relieves minor pain associated with:
- arthritis
- simple backache
- muscle strains
- sprains
- bruises
- cramps
Warnings:
For external use only
When Using This Product
- use only as directed
- do not bandage tightly or use with a heating pad
- do not overwrap or wrap strips over themselves
- do not wrap around neck
- do not apply over large areas of the body or apply in strips longer than 6 inches
- avoid contact with eyes and mucous membranes
- do not apply to wounds or damaged, 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
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:
- tear or cut roll to desired size
- carefully remove backing from one end of strip and place on affected area
- remove remaining backing and press into place
- wear Icy Hot Medicated Roll for up to 8 hours
- repeat as necessary, but no more than 3 to 4 times daily
children 12 years or younger: ask a doctor
Other
Keep carton as it contains important information for usage of this product.
Distributed by Chattem, Inc.
P.O. Box 2219
Chattanooga, TN 37409-0219 USA
© 2009 www.icyhot.com
MADE IN JAPAN
[NDC Code]
Principal Display Panel - Medium Roll, Pouch
Reseal Pouch After Opening
ICY HOT® MEDICATED ROLL
Menthol 7.5%
CUSTOMIZED PAIN RELIEF
- Tear or Cut to Any Length
- Lasts up to 8 Hours
- Comfortable, Flexible, Stays in Place
EXTRA STRENGTH
MEDIUM - 2"
Pain Relieving Ointment on Breathable, Flexible Fabric
2" x 60" (5 cm x 150 cm)
Principal Display Panel - Large Roll, Pouch
Reseal Pouch After Opening
ICY HOT® MEDICATED ROLL
Menthol 7.5%
CUSTOMIZED PAIN RELIEF
- Tear or Cut to Any Length
- Lasts up to 8 Hours
- Comfortable, Flexible, Stays in Place
EXTRA STRENGTH
LARGE - 3"
Pain Relieving Ointment on Breathable, Flexible Fabric
3" x 43" (7.5 cm x 110 cm)
* Please review the disclaimer below.