Ndc 59088-243 Methyl Salicylate 10%

Ndc 59088-243 Methyl Salicylate 10%
SPL v1
SPL
SPL Set ID 376493eb-5142-db6d-e063-6294a90a1e73
Route
TOPICAL
Published
Effective Date 2025-06-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (100 mg)
Inactive Ingredients
Menhaden Oil Propylene Glycol Polyoxyl 20 Cetostearyl Ether Aloe Vera Leaf Borage Seed Oil Carbomer Homopolymer Type B (allyl Sucrose Crosslinked) Cetostearyl Alcohol Cetyl Alcohol Eucalyptus Oil Fructose Phenoxyethanol Water Squalane Stearic Acid Stearyl Alcohol Edetate Sodium .alpha.-tocopherol Acetate, Dl- Grape Seed Oil Sodium Hydroxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-10-14

Description

Methyl Salicylate 10.0%

Purpose

Topical Analgesic


Medication Information

Purpose

Topical Analgesic

Description

Methyl Salicylate 10.0%

Uses

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

Section 44425-7

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

Section 50565-1

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

Section 53414-9

■ If pregnant or breastfeeding ■ ask a health professional before use.

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

Active Ingredients

Methyl Salicylate 10.0%

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.

Methyl Salicylate 10%

Manufactured in the USA by:

PureTek Corporation


Panorama City, CA 91402

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

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 A 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.


Structured Label Content

Uses

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

Section 44425-7 (44425-7)

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

Section 50565-1 (50565-1)

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

Section 53414-9 (53414-9)

■ If pregnant or breastfeeding ■ ask a health professional before use.

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

Active Ingredients (Active ingredients)

Methyl Salicylate 10.0%

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.

Methyl Salicylate 10%

Manufactured in the USA by:

PureTek Corporation


Panorama City, CA 91402

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

When Using This Product (When using this product)

■ Avoid contact with eyes ■ Do not bandage tightly ■ Do not apply to wounds or broken skin ■ 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 A Doctor If (Stop use and ask a 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.


Advanced Ingredient Data


Raw Label Data

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