Icy Hot

Manufacturer
Chattem, Inc.
Effective date
2004-02-01
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 23:14:35

Label at a glance#

ProductIcy Hot
Active ingredientMENTHOL
Label structure16 sections

Indications and uses

temporarily relieves minor pain associated with: arthritis bursitis tendonitis muscle strains sprains bruises cramps

Dosage and administration

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 shoul...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts
Icy Hot Medicated Sleeve - Small

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol 16%

Purpose

OTC - PURPOSE SECTION

Topical analgesic

Uses

INDICATIONS & USAGE SECTION

temporarily relieves minor pain associated with:

  • arthritis
  • bursitis
  • tendonitis
  • muscle strains
  • sprains
  • bruises
  • cramps

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

■ 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

OTC - STOP USE SECTION

  • 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,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Wrist and Elbow Application DiagramsWrist and Elbow Application Diagrams

Directions

DOSAGE & ADMINISTRATION SECTION

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

INACTIVE INGREDIENT SECTION

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)

SPL UNCLASSIFIED SECTION

Drug Facts
Icy Hot Medicated Sleeve - Large

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol 16%

Purpose

OTC - PURPOSE SECTION

Topical analgesic

Uses

INDICATIONS & USAGE SECTION

temporarily relieves minor pain associated with:

  • arthritis
  • bursitis
  • tendonitis
  • muscle strains
  • sprains
  • bruises
  • cramps

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

■ 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

OTC - STOP USE SECTION

  • 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,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Elbow and Knee Application DiagramsElbow and Knee Application Diagrams

Directions

DOSAGE & ADMINISTRATION SECTION

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

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.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 circumferencePRINCIPAL 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

PACKAGE LABEL.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 circumferencePRINCIPAL 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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
MENTHOLACTIVE INGREDIENTL7T10EIP3A1
MENTHOLACTIVE MOIETYL7T10EIP3A1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCN1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QP1
DIETHYLENE GLYCOL MONOETHYL ETHERINACTIVE INGREDIENTA1A1I8X02B1
DIISOPROPYL ADIPATEINACTIVE INGREDIENTP7E6YFV72X1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86K1
GLYCERININACTIVE INGREDIENTPDC6A3C0OX1
GLYCERYL DILAURATEINACTIVE INGREDIENTMFL3ZIE8SK1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE41
MENTHYL LACTATE, (-)-INACTIVE INGREDIENT2BF9E65L7I1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9T1
PEG-150 STEARATEINACTIVE INGREDIENT7BSG7DF10Q1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3T1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8H1
SOY STEROLINACTIVE INGREDIENTPL360EPO9J1
WATERINACTIVE INGREDIENT059QF0KO0R1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEE1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
41167-083041167-0830-0
41167-084441167-0844-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 32 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 9 · 486 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KCAPSULE / ORAL5 mgExact identifier — unii candidate
77 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSOLUTION / ORAL346 mgExact identifier — unii candidate
79 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HSUPPOSITORY / VAGINAL28 mgExact identifier — unii candidate
78 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KCREAM / VAGINAL3 mgExact identifier — unii candidate
77 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HELIXIR / ORAL2.5 mg/15mlExact identifier — unii candidate
78 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION/ DROPS / OPHTHALMIC2.5 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPTROCHE / ORAL12 mgExact identifier — unii candidate
88 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXDOUCHE / VAGINAL1 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4TABLET, EXTENDED RELEASE / ORAL529 mgExact identifier — unii candidate
21 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSOLUTION / NASAL100 mg/100mlExact identifier — unii candidate
77 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / NASAL25 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HINJECTION / INTRA-ARTICULAR4 mgExact identifier — unii candidate
78 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSYSTEM / TOPICAL42 mgExact identifier — unii candidate
79 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCREAM / VAGINAL60 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCONCENTRATE / ORAL1800 mgExact identifier — unii candidate
75 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION, EMULSION / INTRAVENOUS59 mgExact identifier — unii candidate
77 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / TOPICAL17 mgExact identifier — unii candidate
88 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HTABLET, EXTENDED RELEASE / ORAL10 mgExact identifier — unii candidate
78 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNLOTION / TOPICAL1140 mgExact identifier — unii candidate
20 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSOLUTION / TOPICAL1 mgExact identifier — unii candidate
77 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION/ DROPS / AURICULAR (OTIC)0.04 %w/wExact identifier — unii candidate
88 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HINJECTION, POWDER, FOR SUSPENSION / INTRAMUSCULAR4 mgExact identifier — unii candidate
78 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HSOLUTION / OPHTHALMIC8 mgExact identifier — unii candidate
78 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSYSTEM / IONTOPHORESIS168.1 mgExact identifier — unii candidate
75 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION/ DROPS / TOPICAL0.01 %w/vExact identifier — unii candidate
88 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION, CONCENTRATE / ORAL200 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
DIETHYLENE GLYCOL MONOETHYL ETHERDIETHYLENE GLYCOL MONOETHYL ETHERA1A1I8X02BLOTION / TOPICAL714 mgExact identifier — unii candidate
6 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNAEROSOL, FOAM / RECTAL17 mgExact identifier — unii candidate
20 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLIQUID / ORAL2400 mgExact identifier — unii candidate
75 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HINJECTION, SUSPENSION / SUBCUTANEOUS0.3 %w/vExact identifier — unii candidate
78 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TINJECTION / INFILTRATION80 mgExact identifier — unii candidate
79 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSYRUP / ORAL16734 mgExact identifier — unii candidate
75 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HINJECTION, SUSPENSION / INTRAMUSCULAR4 mgExact identifier — unii candidate
78 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXELIXIR / ORAL5621 mgExact identifier — unii candidate
75 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSUSPENSION/ DROPS / AURICULAR (OTIC)0.01 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TINJECTION, SOLUTION / INTRAMUSCULAR45 mgExact identifier — unii candidate
79 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXJELLY / TOPICALNAExact identifier — unii candidate
75 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEEGRANULE, FOR SUSPENSION / ORAL450 mgExact identifier — unii candidate
29 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEEGRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL2350 mgExact identifier — unii candidate
29 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TPOWDER, FOR SUSPENSION / ORAL75 mgExact identifier — unii candidate
79 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL23 mgExact identifier — unii candidate
21 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSOLUTION / RECTAL97 mgExact identifier — unii candidate
77 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSHAMPOO / TOPICAL17 mgExact identifier — unii candidate
88 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HCAPSULE, COATED / ORAL0.04 mgExact identifier — unii candidate
78 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSUSPENSION / OPHTHALMICADJ PHExact identifier — unii candidate
88 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCREAM / TOPICAL1720 mgExact identifier — unii candidate
75 equally ranked IID candidates
DIETHYLENE GLYCOL MONOETHYL ETHERDIETHYLENE GLYCOL MONOETHYL ETHERA1A1I8X02BOINTMENT / TOPICAL5 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HINJECTION / INTRAMUSCULAR4 %w/vExact identifier — unii candidate
78 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSPRAY / RESPIRATORY (INHALATION)0.05 %w/wExact identifier — unii candidate
77 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KTABLET / ORAL100 mgExact identifier — unii candidate
77 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPELIXIR / ORAL100 mg/5mlExact identifier — unii candidate
88 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KAEROSOL, FOAM / RECTAL2 mgExact identifier — unii candidate
77 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXPASTE / DENTAL20 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HGRANULE, FOR SUSPENSION / ORAL240 mgExact identifier — unii candidate
78 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSPRAY, METERED / NASAL2 mgExact identifier — unii candidate
88 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSUSPENSION / TOPICAL0.24 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSUSPENSION / RESPIRATORY (INHALATION)0.03 %w/vExact identifier — unii candidate
88 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUPPOSITORY / RECTAL440 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4CREAM / TOPICAL836 mgExact identifier — unii candidate
21 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION/ DROPS / AURICULAR (OTIC)25 mgExact identifier — unii candidate
75 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
a876a9bd-c797-472a-94e7-8296fe717802ff24f080-33ca-4c97-9739-625bb58a39fe2023-06-06WarningsExact identifier
spl set id: ff24f080-33ca-4c97-9739-625bb58a39fe

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.