FDA.reportPublic FDA data

Icy Hot

Manufacturer
A-S Medication Solutions
Effective date
2021-04-16
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 22:47:05

Label at a glance#

ProductIcy Hot Pain Relieving Cream
Active ingredientMENTHOL, METHYL SALICYLATE
Label structure21 sections

Indications and uses

temporarily relieves minor pain associated with: arthritis simple backache muscle strains sprains bruises cramps

Dosage and administration

adults and children over 12 years: apply a thin layer to affected area massage into painful area until thoroughly absorbed into skin repeat as necessary, but not more than 4 times daily children 12 years or younger: ask a doctor

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

ICYHOT® PAIN RELIEVING STICK
Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol 10%

Methyl salicylate 30%

Purpose

OTC - PURPOSE SECTION

Topical analgesic

Uses

INDICATIONS & USAGE SECTION

temporarily relieves minor pain associated with:

  • arthritis
  • simple backache
  • muscle strains
  • sprains
  • bruises
  • cramps

Warnings

WARNINGS SECTION

For external use only

SEE INSIDE LABEL FOR COMPLETE DRUG FACTS

Allergy Alert: If prone to allergic reaction from aspirin or salicylates, consult a doctor before use.

When using this product

OTC - WHEN USING SECTION

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

■ 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 or apply local heat (such as heating pads) or a medicated patch 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

■ do not expose the area treated with product to heat or direct sunlight

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

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health care 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.

Directions

DOSAGE & ADMINISTRATION SECTION

adults and children over 12 years:

  • apply a thin layer to affected area
  • massage into painful area until thoroughly absorbed into skin
  • repeat as necessary, but not more than 4 times daily

children 12 years or younger: ask a doctor

Inactive ingredients

INACTIVE INGREDIENT SECTION

ceresin, cyclomethicone, hydrogenated castor oil, microcrystalline wax, paraffin, PEG-150 distearate, propylene glycol, stearic acid, stearyl alcohol (245-111)





ICYHOT® PAIN RELIEVING BALM
Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol 7.6%

Methyl salicylate 29%

Purpose

OTC - PURPOSE SECTION

Topical analgesic

Uses

INDICATIONS & USAGE SECTION

temporarily relieves minor pain associated with:

  • arthritis
  • simple backache
  • muscle strains
  • sprains
  • bruises
  • cramps

Warnings

WARNINGS SECTION

For external use only

Allergy alert: if prone to allergic reaction from aspirin or salicylates, consult a doctor before use

When using this product

OTC - WHEN USING SECTION

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

■ 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 or apply local heat (such as heating pads) or a medicated patch to the area of use

■ do not use at the same time as other topical analgesics

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

■ if severe burning sensation occurs, discontinue use immediately

■ do not expose the area treated with product to heat or direct sunlight

■ avoid applying into skin folds

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.

Directions

DOSAGE & ADMINISTRATION SECTION

adults and children over 12 years:

■ apply a thin layer to affected area

■ massage into painful area until thoroughly absorbed into skin

■ repeat as necessary, but no more than 4 times daily

■ AFTER APPLYING, WASH HANDS WITH SOAP AND WATER

children 12 years or younger: ask a doctor

Inactive ingredients

INACTIVE INGREDIENT SECTION

paraffin, white petrolatum






ICYHOT® PAIN RELIEVING CREAM
Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol 10%

Methyl salicylate 30%

Purpose

OTC - PURPOSE SECTION

Topical analgesic

Uses

INDICATIONS & USAGE SECTION

temporarily relieves minor pain associated with:

  • arthritis
  • simple backache
  • muscle strains
  • sprains
  • bruises
  • cramps

Warnings

WARNINGS SECTION

For external use only

Allergy alert: if prone to allergic reaction from aspirin or salicylates, consult a doctor before use

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 or apply local heat (such as heating pads) or a medicated patch to the area of use

■ do not use at the same time as other topical analgesics

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

■ if severe burning sensation occurs, discontinue use immediately

■ do not expose the area treated with product to heat or direct sunlight

■ avoid applying into skin folds

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.

Directions

DOSAGE & ADMINISTRATION SECTION

adults and children over 12 years:

■ apply a thin layer to affected area

■ massage into painful area until thoroughly absorbed into skin

■ repeat as necessary, but no more than 4 times daily

■ AFTER APPLYING, WASH HANDS WITH SOAP AND WATER

children 12 years or younger: ask a doctor

Inactive ingredients

INACTIVE INGREDIENT SECTION

carbomer, cetearyl alcohol, cetyl esters, oleth-3 phosphate, polysorbate 60, stearic acid, triethanolamine, water

Close cap tightly after use.

HOW SUPPLIED

HOW SUPPLIED SECTION

Product: 50090-4357

NDC: 50090-4357-0 35.4 g in a TUBE / 1 in a CARTON

Menthol and Methyl Salicylate

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label Image
Label Image

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-4357-02023-02-07C16284748780-1f386c64a-36c9-0266-e053-dadaa90a7c1aIcy Hot
50090-4357-02023-01-30C16284748780-1f386c64a-36c9-0266-e053-dadaa90a7c1aIcy Hot

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
41167-0088-1GM - Gram41167-008832a8d1a7-ab44-4156-a09c-e21b9e1859d812021-08-05
41167-0088-5GM - Gram41167-00887842dfa3-3a3a-4cd5-a54f-47ae0d73f2a112021-08-05

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50090-435750090-4357-0
41167-0088

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
MENTHOLL7T10EIP3AACTIB
METHYL SALICYLATELAV5U5022YACTIB
CETYL ESTERS WAXD072FFP9GUIACT
OLETH-3 PHOSPHATE8Q0Z18J1VLIACT
STEARIC ACID4ELV7Z65APIACT
WATER059QF0KO0RIACT
TROLAMINE9O3K93S3TKIACT

Source Document#

Source XML

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Icy Hot Pain Relieving BalmMENTHOL AND METHYL SALICYLATEChattem, Inc.40c8c02f-fa5f-4e80-81a0-48271fa6f94b2026-06-12WarningsExact identifier
ndc (product): 41167-0088
591c2256-a5df-4735-8f7e-464be8892a41fbe6178e-569d-42b1-80e1-3541b7cdb71c2023-02-04WarningsExact identifier
spl set id: fbe6178e-569d-42b1-80e1-3541b7cdb71c

Reported adverse events (FAERS/openFDA)#

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