ICY HOT MEDICATED ROLL, MEDIUM- menthol patch ICY HOT MEDICATED ROLL, LARGE- menthol patch

Icy Hot by

Drug Labeling and Warnings

Icy Hot by is a Otc medication manufactured, distributed, or labeled by Nichiban Company Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

SPL UNCLASSIFIED SECTION

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)

Medium Roll Pouch

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)

Large Roll Pouch

INGREDIENTS AND APPEARANCE

ICY HOT  MEDICATED ROLL, MEDIUM
menthol patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 44014-085
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	787.5 mg

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 44014-085-01	1 in 1 POUCH
2	NDC: 44014-085-03	170 in 1 BOX

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	04/01/2009

ICY HOT  MEDICATED ROLL, LARGE
menthol patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 44014-086
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	866.25 mg

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 44014-086-07	1 in 1 POUCH
2	NDC: 44014-086-02	150 in 1 BOX

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	04/01/2009

Labeler - Nichiban Company Limited (690544325)

Establishment
Name	Address	ID/FEI	Business Operations
Nichiban Company Limited		690544325	ANALYSIS, MANUFACTURE