ICY HOT- menthol patch
Chattem, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Icy Hot Medicated Sleeve

Drug Facts
Icy Hot Medicated Sleeve - Small

Active ingredient

Menthol 16%

Purpose

Topical analgesic

Uses

temporarily relieves minor pain associated with:

arthritis
bursitis
tendonitis
muscle strains
sprains
bruises
cramps

Warnings

For external use only

When using this product

■ use only as directed. Read and follow all directions and warnings on this carton.

■ avoid contact with eyes and mucous membranes

■ rare cases of serious burns have been reported with products of this type

■ do not apply to wounds or damaged, broken or irritated skin

■ do not bandage tightly over sleeve or apply local heat (such as heating pads) to the area of use

■ a transient burning sensation may occur upon application but generally disappears in several days

■ if severe burning sensation occurs, discontinue use immediately

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
you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied

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.

Wrist and Elbow Application Diagrams

Directions

adults and children over 12 years:

remove plastic insert and discard
pull ICY HOT® SLEEVE onto ankle, elbow or wrist – note: medicine is away from skin
carefully pull ICY HOT® SLEEVE over itself, medicine will then be touching the skin
note: the drawing (above) should help you understand how to do this
apply one ICY HOT® SLEEVE to affected area
repeat as necessary, but no more than 3 times daily
sleeve should feel snug but not tight

children 12 years or younger: ask a doctor

Inactive ingredients

cetyl alcohol, diethylene glycol monoethyl ether, diisopropyl adipate, disodium EDTA, glycerin, glyceryl dilaurate, glyceryl stearate, menthyl lactate, methylparaben, PEG-150 stearate, phenoxyethanol, polysorbate 80, soya sterol, water, xanthan gum (may contain citric acid) (245-39)

Drug Facts
Icy Hot Medicated Sleeve - Large

Active ingredient

Menthol 16%

Purpose

Topical analgesic

Uses

temporarily relieves minor pain associated with:

arthritis
bursitis
tendonitis
muscle strains
sprains
bruises
cramps

Warnings

For external use only

When using this product

■ use only as directed. Read and follow all directions and warnings on this carton.

■ avoid contact with eyes and mucous membranes

■ rare cases of serious burns have been reported with products of this type

■ do not apply to wounds or damaged, broken or irritated skin

■ do not bandage tightly over sleeve or apply local heat (such as heating pads) to the area of use

■ a transient burning sensation may occur upon application but generally disappears in several days

■ if severe burning sensation occurs, discontinue use immediately

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
you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied

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.

Elbow and Knee Application Diagrams

Directions

adults and children over 12 years:

remove plastic insert and discard
pull ICY HOT® SLEEVE onto ankle, elbow or knee – note: medicine is away from skin
carefully pull ICY HOT® SLEEVE over itself, medicine will then be touching the skin
note: the drawing (above) should help you understand how to do this
apply one ICY HOT® SLEEVE to affected area
repeat as necessary, but no more than 3 to 4 times daily
sleeve should feel snug but not tight

children 12 years or younger: ask a doctor

Inactive ingredients

cetyl alcohol, citric acid, diisopropyl adipate, disodium EDTA, ethoxydiglycol, glycerin, glyceryl dilaurate, glyceryl stearate, glycine soja sterols, menthyl lactate, methylparaben, PEG-150 stearate, phenoxyethanol, polysorbate 80, water, xanthan gum (283-110)

PRINCIPAL DISPLAY PANEL

ICY HOT® MEDICATED SLEEVE
Menthol 16%
SMALL
Ankles, Elbows and Wrists
Contains 3 Individually Wrapped Sleeves
Expands to fit 5” to 12” in circumference

PRINCIPAL DISPLAY PANEL
ICY HOT® MEDICATED SLEEVE
Menthol 16%
SMALL
Ankles, Elbows and Wrists
Contains 3 Individually Wrapped Sleeves
Expands to fit 5” to 12” in circumference

PRINCIPAL DISPLAY PANEL

ICY HOT® MEDICATED SLEEVE
Menthol 16%
LARGE
Ankles, Elbows and Knees
Contains 3 Individually Wrapped Sleeves
Expands to fit 8” to 24” in circumference

PRINCIPAL DISPLAY PANEL
ICY HOT® MEDICATED SLEEVE
Menthol 16%
LARGE
Ankles, Elbows and Knees
Contains 3 Individually Wrapped Sleeves
Expands to fit 8” to 24” in circumference

ICY HOT
menthol patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:41167-0830
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	336 mg

Ingredient Name	Strength
Inactive Ingredients
CETYL ALCOHOL (UNII: 936JST6JCN)
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)
DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL DILAURATE (UNII: MFL3ZIE8SK)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I)
METHYLPARABEN (UNII: A2I8C7HI9T)
PEG-150 STEARATE (UNII: 7BSG7DF10Q)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
SOY STEROL (UNII: PL360EPO9J)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:41167-0830-0	3 in 1 CARTON	02/01/2004	03/25/2015
1		1 in 1 POUCH; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	02/01/2004	03/25/2015

ICY HOT
menthol patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:41167-0844
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	336 mg

Ingredient Name	Strength
Inactive Ingredients
CETYL ALCOHOL (UNII: 936JST6JCN)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)
EDETATE DISODIUM (UNII: 7FLD91C86K)
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL DILAURATE (UNII: MFL3ZIE8SK)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I)
METHYLPARABEN (UNII: A2I8C7HI9T)
PEG-150 STEARATE (UNII: 7BSG7DF10Q)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:41167-0844-1	3 in 1 CARTON	02/01/2004	05/31/2023
1		1 in 1 POUCH; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	02/01/2004	05/31/2023

Labeler - Chattem, Inc. (003336013)

Revised: 6/2023

Document Id: a876a9bd-c797-472a-94e7-8296fe717802

Set id: ff24f080-33ca-4c97-9739-625bb58a39fe

Version: 4

Effective Time: 20230606

Chattem, Inc.