Mencylate

Mencylate
SPL v3
SPL
SPL Set ID f824de86-9492-2e6b-e053-6294a90a6f2a
Route
TOPICAL
Published
Effective Date 2023-03-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (100 mg) Menthol (20 mg)
Inactive Ingredients
Aloe Vera Leaf Propylene Glycol Borage Seed Oil Carbomer 934 Polyoxyl 20 Cetostearyl Ether 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 2023-03-24

Description

Menthol 2.0% Methyl Salicylate 10.0%

Purpose

Topical Analgesic


Medication Information

Purpose

Topical Analgesic

Description

Menthol 2.0% Methyl Salicylate 10.0%

Uses

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

Do Not

• apply on wounds or damaged skin • bandage tightly

Warnings

For external use only.

Directions

• Adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily. • Children under 12 years of age: consult a doctor.

Mencylate Tm

Manufactured in the USA by:

PureTek Corporation

Panorama City, CA 91402

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

Other Information

• Store at controlled room temperature 20°-25°C (68°-77°F).

Active Ingredients



Menthol 2.0%

Methyl Salicylate 10.0%

Inactive Ingredients:

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

When Using This Product

• avoid contact with the eyes or mucous membranes • do not use other than as directed

Stop Use and Ask A Doctor If

• condition worsens • symptoms persist for more than 7 days or clear up and occur again within a few days

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

Uses

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

Do Not (Do not)

• apply on wounds or damaged skin • bandage tightly

Purpose

Topical Analgesic

Warnings

For external use only.

Directions

• Adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily. • Children under 12 years of age: consult a doctor.

Mencylate Tm (Mencylate TM)

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 controlled room temperature 20°-25°C (68°-77°F).

Active Ingredients (Active ingredients)



Menthol 2.0%

Methyl Salicylate 10.0%

Inactive Ingredients: (Inactive ingredients:)

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

When Using This Product (When using this product)

• avoid contact with the eyes or mucous membranes • do not use other than as directed

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

• condition worsens • symptoms persist for more than 7 days or clear up and occur again within a few days

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

If swallowed, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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