Drug Facts

Composition & Product

Active Ingredients

Menthol (787.5 mg)

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2009-04-01

Medication Information

Purpose

Topical analgesic

Description

Menthol 7.5%

Uses

temporarily relieves minor pain associated with:

arthritis
simple backache
muscle strains
sprains
bruises
cramps

Section 42229-5

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

MADE IN JAPAN

[NDC Code]

Warnings:

For external use only

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

Active Ingredient

Menthol 7.5%

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.

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

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

Structured Label Content

Uses

temporarily relieves minor pain associated with:

arthritis
simple backache
muscle strains
sprains
bruises
cramps

Section 42229-5 (42229-5)

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

MADE IN JAPAN

[NDC Code]

Purpose

Topical analgesic

Warnings:

For external use only

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

Active Ingredient (Active ingredient)

Menthol 7.5%

When Using This Product (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: (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, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

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

Principal Display Panel Large 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

Principal Display Panel Medium Roll, Pouch (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

Advanced Ingredient Data

[{"name": "MENTHOL", "unii": "L7T10EIP3A", "classCode": "ACTIB", "strengthNumerator": "787.5", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "MENTHOL", "unii": "L7T10EIP3A", "classCode": "ACTIB", "strengthNumerator": "866.25", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}]

Raw Label Data

All Sections (JSON)

{"Uses": "temporarily relieves minor pain associated with: arthritis simple backache muscle strains sprains bruises cramps", "42229-5": "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]", "Purpose": "Topical analgesic", "Warnings:": "For external use only", "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", "Active ingredient": "Menthol 7.5%", "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.", "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", "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"}

Drug Facts

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information