SPL v1
SPL
SPL Set ID eaa3389c-a49c-4b4b-94f7-3b41fe9cae79
Route
TOPICAL
Published
Effective Date 2024-03-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (10 g)
Inactive Ingredients
Menthol Castor Oil Gelatin Tartaric Acid Polysorbate 80 Polyvinyl Alcohol, Unspecified Polyacrylic Acid (450000 Mw) Glycerin Water Edetate Disodium Sodium Polyacrylate (8000 Mw) Dihydroxyaluminum Aminoacetate Carboxymethylcellulose Sodium, Unspecified

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-03-06

Description

Methyl Salicylate 10% w/w.

Purpose

Topical analgesic

Storage and Handling

Store between 15-30℃(59-86℉) keep away from children


Medication Information

Purpose

Topical analgesic

Storage and Handling

Store between 15-30℃(59-86℉) keep away from children

Description

Methyl Salicylate 10% w/w.

Use

For the temporary relief of minor aches and pains of muscles and joints associated with backache, lumbago, strains, buries, sprains and arthritis or rheumatic pain, or pain of tendons and ligaments.

Warnings

For external use only.

Do not apply to sensitive skin or open wounds.

Avoid contact with eyes or mucous membranes

If excessive redness, burning or discomfort of the skin develop, discontinue use and consult a healthcare practitioner.

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 healthcare practitioner.

Never use this product with any other heating or cooling device or with other external analgesic products.

The application of external heat, such as an electric heating pad, may result in excessive skin irritation or burn.

Do not bandage this product or cover with anything other than light clothing

Do not use this product if you are allergic to salicylates or if you are taking anticoagulant medications.

Directions

For use by adults and children 12 years of age and older:

Open resealable pouch and remove patch

If desired, cut patch to size

Peel off protective film and apply sticky side to desired area

Apply patch to affected area not more than 3 to 4 times daily and for no longer than 1-2 hours per application

Remove patch before applying a new one

Dispose of patch in waste receptacle after use

Do Not Use

on wounds, cuts, damaged or infected skin

On eyes, mouth, genitals, or any other mucous membranes

Active Ingredient(s)

Methyl Salicylate 10% w/w.

Inactive Ingredients

castor oil, dihydroxyaluminum aminoacetate, edetate disodium, gelatin, glycerine, menthol. Polyacrylic acid, polysorbate 80, polyvinyl alcohol, sodium carboxymethyl cellulose, sodium polyacrylate, tartaric acid, water

When Using This Product:

You may experience a burning sensation. The intensity of this reaction varies among individuals and may be sever. With regular use, this sensation generally disappears after several days.

Avoid contact with the eyes, lips, nose and mucous membranes

Do not tightly wrap or bandage the treated area

Do not apply heat to the treated area immediately before or after use

Keep Out of Reach of Children

Children 12 years of age and under: should only use this product upon the advice of a healthcare practitioner.

Stop Use and Ask A Doctor If:

Allergic reaction occurs

Condition worsens or does not improve within 7 days

Symptoms clear up and return within a few days

Redness, irritation, swelling, pain or other symptoms begin or increase

Package Label Principal Display Panel


Structured Label Content

Use

For the temporary relief of minor aches and pains of muscles and joints associated with backache, lumbago, strains, buries, sprains and arthritis or rheumatic pain, or pain of tendons and ligaments.

Purpose

Topical analgesic

Warnings

For external use only.

Do not apply to sensitive skin or open wounds.

Avoid contact with eyes or mucous membranes

If excessive redness, burning or discomfort of the skin develop, discontinue use and consult a healthcare practitioner.

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 healthcare practitioner.

Never use this product with any other heating or cooling device or with other external analgesic products.

The application of external heat, such as an electric heating pad, may result in excessive skin irritation or burn.

Do not bandage this product or cover with anything other than light clothing

Do not use this product if you are allergic to salicylates or if you are taking anticoagulant medications.

Directions

For use by adults and children 12 years of age and older:

Open resealable pouch and remove patch

If desired, cut patch to size

Peel off protective film and apply sticky side to desired area

Apply patch to affected area not more than 3 to 4 times daily and for no longer than 1-2 hours per application

Remove patch before applying a new one

Dispose of patch in waste receptacle after use

Do Not Use (Do not use)

on wounds, cuts, damaged or infected skin

On eyes, mouth, genitals, or any other mucous membranes

Active Ingredient(s)

Methyl Salicylate 10% w/w.

Inactive Ingredients (Inactive ingredients)

castor oil, dihydroxyaluminum aminoacetate, edetate disodium, gelatin, glycerine, menthol. Polyacrylic acid, polysorbate 80, polyvinyl alcohol, sodium carboxymethyl cellulose, sodium polyacrylate, tartaric acid, water

Storage and Handling (STORAGE AND HANDLING)

Store between 15-30℃(59-86℉) keep away from children

When Using This Product: (When using this product:)

You may experience a burning sensation. The intensity of this reaction varies among individuals and may be sever. With regular use, this sensation generally disappears after several days.

Avoid contact with the eyes, lips, nose and mucous membranes

Do not tightly wrap or bandage the treated area

Do not apply heat to the treated area immediately before or after use

Keep Out of Reach of Children (KEEP OUT OF REACH OF CHILDREN)

Children 12 years of age and under: should only use this product upon the advice of a healthcare practitioner.

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

Allergic reaction occurs

Condition worsens or does not improve within 7 days

Symptoms clear up and return within a few days

Redness, irritation, swelling, pain or other symptoms begin or increase

Package Label Principal Display Panel (Package Label - Principal Display Panel)


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