Ndc 59088-245 Methylten 25%

Ndc 59088-245 Methylten 25%
SPL v1
SPL
SPL Set ID 3767b97e-ab0c-ac26-e063-6394a90a00cf
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
Phenoxyethanol Eucalyptus Oil Water Aloe Vera Leaf Stearyl Alcohol .alpha.-tocopherol Acetate Sodium Hydroxide Squalane Borage Seed Oil Cetyl Alcohol Stearic Acid Carbomer Homopolymer, Unspecified Type Cetostearyl Alcohol Fructose Polyoxyl 20 Cetostearyl Ether Propylene Glycol Edetate Sodium Grape Seed Oil

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.

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.

Methylten™ 25%

Manufactured in the USA by:

PureTek Corporation


Panorama City, CA 91402

Questions? Call toll-free: 1 -877-921-7873

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.

When Using This Product

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

Stop Use and Ask A 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.

Methylten™ 25%

Manufactured in the USA by:

PureTek Corporation


Panorama City, CA 91402

Questions? Call toll-free: 1 -877-921-7873

Other Information (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.

When Using This Product (When using this product)

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

Stop Use and Ask A Doctor If (Stop use and ask a 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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