Methylten Cream

Methylten Cream
SPL v1
SPL
SPL Set ID 28f4093f-803f-0e70-e063-6294a90a98a4
Route
TOPICAL
Published
Effective Date 2024-12-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (1 mg)
Inactive Ingredients
Propylene Glycol Sodium Hydroxide .alpha.-tocopherol Acetate Stearic Acid Aqua Phenoxyethanol Fructose Cetearyl Alcohol Vitis Vinifera (grape) Seed Oil Carbomer Cetyl Alcohol Tetrasodium Edta Eucalyptus Globulus Leaf Oil Aloe Barbadensis Leaf Juice Squalane Borago Officinalis Seed Oil Stearyl Alcohol Ceteareth-20

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-01-13

Description

Methyl Salicylate 10%

Purpose

Topical Analgesic


Medication Information

Purpose

Topical Analgesic

Description

Methyl Salicylate 10%

Uses:

For the temporary relief of minor aches and pains of muscles and joints.

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

Methyltentm

Manufactured by:

PureTek Corporation


Panorama City, CA 91402

For questions or information

call toll-free: 877-921-7873

Other Information

■ store between 20° to 25° C (68°- 77° F)

Active Ingredients:

Methyl Salicylate 10%

Inactive Ingredients:

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

When Using This Product

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

Stop Use and Ask Doctor If

■ pain persists for more than 7 days, redness is present or in conditions affecting children under 12 years of age. ■ excessive irritation of the skin develops. ■ if pregnant or breastfeeding ■ ask a health professional before use.


Structured Label Content

Uses:

For the temporary relief of minor aches and pains of muscles and joints.

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

Methyltentm (MethyltenTM)

Manufactured by:

PureTek Corporation


Panorama City, CA 91402

For questions or information

call toll-free: 877-921-7873

Other Information (Other information)

■ store between 20° to 25° C (68°- 77° F)

Active Ingredients:

Methyl Salicylate 10%

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 , Eucalyptus Globus Leaf Oil, Fructose, Phenoxyethanol, Propylene Glycol, Sodium Hydroxide, Squalane, Stearic Acid, Stearyl Alcohol, Tetrasodium EDTA, Tocopheryl Acetate, Vitis Vinifera (Grape) Seed Oil, Fragrance.

When Using This Product (When using this product)

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

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

■ pain persists for more than 7 days, redness is present or in conditions affecting children under 12 years of age. ■ excessive irritation of the skin develops. ■ if pregnant or breastfeeding ■ ask a health professional before use.


Advanced Ingredient Data


Raw Label Data

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