ICY HOT MEDICATED ROLL, MEDIUM (menthol) patch
ICY HOT MEDICATED ROLL, LARGE (menthol) patch
[Nichiban Company Limited]

NOTE:MOST OTC DRUGS ARE NOT REVIEWED AND APPROVED BY FDA, HOWEVER THEY MAY BE MARKEDTED IF THEY COMPLY WITH APPLICABLE REGULATIONS AND POLICIES. FDA HAS NOT EVALUATED WHETHER THIS PRODUCT COMPLIES.

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

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 & 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	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (MENTHOL)	MENTHOL	787.5 mg

Packaging
#	Item Code	Package Description
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	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (MENTHOL)	MENTHOL	866.25 mg

Packaging
#	Item Code	Package Description
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

Revised: 12/2009

Document Id: 3656d7ee-bd4c-422c-8e4b-f24517dddc57

Set id: 3656d7ee-bd4c-422c-8e4b-f24517dddc57

Version: 1

Effective Time: 20091223

Nichiban Company Limited