Ndc 59088-014 Methyl Salicylate 25%

Ndc 59088-014 Methyl Salicylate 25%
SPL v2
SPL
SPL Set ID 376797ff-cf13-a3c6-e063-6394a90a9de1
Route
TOPICAL
Published
Effective Date 2025-06-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (250 mg)
Inactive Ingredients
Propylene Glycol .alpha.-tocopherol Acetate Stearic Acid Ceteareth-20 Aqua Phenoxyethanol Fructose Cetearyl Alcohol Vitis Vinifera (grape) Seed Oil Carbomer Cetyl Alcohol Tetrasodium Edta Eucalyptus Globulus Leaf Oil Aloe Vera Leaf Squalane Borago Officinalis Seed Oil Stearyl Alcohol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-06-12

Description

Methyl Salicylate 25%

Purpose

Topical Analgesic


Medication Information

Purpose

Topical Analgesic

Description

Methyl Salicylate 25%

Uses:

■ For the temporary relief of minor aches and pains of muscle and joints associated with ■ simple backache ■ arthritis ■ strains ■ bruises ■ sprains

Section 50565-1

■ Keep this and all other drugs out of the reach of children.

Purpose:

Topical Analgesic

Warnings:

■ For External Use Only

Directions

■ Use only as directed. Adults and children 2 years and older: Apply to affected area no more than 3 to 4 times daily. ■ Children under 2 years of age: Do not use, consult a physician.

Other Information

■ Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].

Active Ingredients:

Methyl Salicylate 25%

Inactive Ingredients:

Aloe Barbadensis (Aloe Vera) Leaf Juice, Aqua (Purified Water), Borago Officinalis (Borage) Seed Oil, Carbomer, Ceteareth-20, Cetearyl Alcohol, Cetyl Alcohol, DL-Alpha Tocopheryl Acetate, Eucalyptus Globus Leaf Oil, Fructose, Phenoxyethanol, Propylene Glycol, Sodium Hydroxide, Squalane, Stearic Acid, Stearyl Alcohol, Tetrasodium EDTA, Vitis Vinifera (Grape) Seed Oil, Fragrance.

Methyl Salicylate 25%

Manufactured by:

PureTek Corporation


Panorama City, CA 91402

For questions or information

call toll-free: 877-921-7873

When Using This Product

■ Avoid contact with eyes ■ Do not bandage tightly ■ Do not apply to wounds or broken skin

Stop Use and Ask Doctor If

■ If condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a physician.


Structured Label Content

Uses:

■ For the temporary relief of minor aches and pains of muscle and joints associated with ■ simple backache ■ arthritis ■ strains ■ bruises ■ sprains

Section 50565-1 (50565-1)

■ Keep this and all other drugs out of the reach of children.

Purpose:

Topical Analgesic

Warnings:

■ For External Use Only

Directions

■ Use only as directed. Adults and children 2 years and older: Apply to affected area no more than 3 to 4 times daily. ■ Children under 2 years of age: Do not use, consult a physician.

Other Information (Other information)

■ Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].

Active Ingredients:

Methyl Salicylate 25%

Inactive Ingredients: (Inactive ingredients:)

Aloe Barbadensis (Aloe Vera) Leaf Juice, Aqua (Purified Water), Borago Officinalis (Borage) Seed Oil, Carbomer, Ceteareth-20, Cetearyl Alcohol, Cetyl Alcohol, DL-Alpha Tocopheryl Acetate, Eucalyptus Globus Leaf Oil, Fructose, Phenoxyethanol, Propylene Glycol, Sodium Hydroxide, Squalane, Stearic Acid, Stearyl Alcohol, Tetrasodium EDTA, Vitis Vinifera (Grape) Seed Oil, Fragrance.

Methyl Salicylate 25%

Manufactured by:

PureTek Corporation


Panorama City, CA 91402

For questions or information

call toll-free: 877-921-7873

When Using This Product (When using this product)

■ Avoid contact with eyes ■ Do not bandage tightly ■ Do not apply to wounds or broken skin

Stop Use and Ask Doctor If (Stop use and ask doctor if)

■ If condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a physician.


Advanced Ingredient Data


Raw Label Data

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