Toast Freezin' Cold - 78983-104

Toast Freezin' Cold - 78983-104
SPL v1
SPL
SPL Set ID 37b4d363-0099-8cd3-e063-6394a90a18d6
Route
TOPICAL
Published
Effective Date 2025-06-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (11 g) Salicylic Acid (31 g)
Inactive Ingredients
Boswellia Serrata Oil Glycerin Rosmarinus Officinalis (rosemary) Leaf Oil Phenoxyethanol Water Ethylhexylglycerin Cetyl Alcohol Matricaria Chamomilla Flowering Top Oil 1,4-butanediol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-06-01

Description

Menthol 11% Methyl Salicylate 31%

Purpose

Topical analgesic


Medication Information

Purpose

Topical analgesic

Description

Menthol 11% Methyl Salicylate 31%

Uses

for the temporary relief of minor aches and pains of

muscles and joints associated with ■ arthritis ■ strains

■ bruises ■ sprains

Section 51945-4

Warnings

For external use only

Directions

■ Use only as directed

■ adults and children 12 years of age or older:

apply to affected area not more than 3 to 4 times daily

■ children under 12 years of age: consult a physician

Do Not Use

on wounds ■ on damaged skin

■ immediately before or after bathing or using a hot tub

■ with a heating pad ■ under wrapping or bandage

where perspiration is likely to occur

Other Information

■ Store between 20-25° C (68-77°F) ■ protect from freezing

Active Ingredient

Menthol 11%

Methyl Salicylate 31%

Inactive Ingredients

Behentrimonium Methosulfate, Boswellia Serrata Extract, Butylene Glycol, Cetyl Alcohol, Chamomilla Recutita (Matricaria) Flower, Ethylhexylglycerin, Glycerin, Phenoxyethanol, Rosmarinus Officinalis (Rosemary) Leaf Extract, Water

Questions Or Comments?

1-800-4NO-PAIN

When Using This Product

■ Avoid contact with eyes

and mucous membranes ■ do not bandage tightly

If Pregnant Or Breast Feeding

ask a healthcare professional before use.

Keep Out of Reach of Children

In case of accidental ingestion, get medical help or contact a Poison Control Center

Stop Using Consult A Doctor If

■ Condition worsens or

symptoms persist for more than 7 days ■ symptoms clear up

and occur within a few days ■ excessive skin irritation occurs


Structured Label Content

Uses

for the temporary relief of minor aches and pains of

muscles and joints associated with ■ arthritis ■ strains

■ bruises ■ sprains

Section 51945-4 (51945-4)

Purpose

Topical analgesic

Warnings

For external use only

Directions

■ Use only as directed

■ adults and children 12 years of age or older:

apply to affected area not more than 3 to 4 times daily

■ children under 12 years of age: consult a physician

Do Not Use (Do not use)

on wounds ■ on damaged skin

■ immediately before or after bathing or using a hot tub

■ with a heating pad ■ under wrapping or bandage

where perspiration is likely to occur

Other Information (Other information)

■ Store between 20-25° C (68-77°F) ■ protect from freezing

Active Ingredient

Menthol 11%

Methyl Salicylate 31%

Inactive Ingredients (Inactive ingredients)

Behentrimonium Methosulfate, Boswellia Serrata Extract, Butylene Glycol, Cetyl Alcohol, Chamomilla Recutita (Matricaria) Flower, Ethylhexylglycerin, Glycerin, Phenoxyethanol, Rosmarinus Officinalis (Rosemary) Leaf Extract, Water

Questions Or Comments? (Questions or Comments?)

1-800-4NO-PAIN

When Using This Product (When using this product)

■ Avoid contact with eyes

and mucous membranes ■ do not bandage tightly

If Pregnant Or Breast Feeding (If pregnant or breast-feeding)

ask a healthcare professional before use.

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

In case of accidental ingestion, get medical help or contact a Poison Control Center

Stop Using Consult A Doctor If (Stop using consult a doctor if)

■ Condition worsens or

symptoms persist for more than 7 days ■ symptoms clear up

and occur within a few days ■ excessive skin irritation occurs


Advanced Ingredient Data


Raw Label Data

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