Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID fb468409-4202-4de6-b932-1fbb6c3b8256
Route
TOPICAL
Published
Effective Date 2021-04-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (375 mg)
Inactive Ingredients
Glycerin Propylene Glycol Gelatin Carboxymethylcellulose Sodium, Unspecified Kaolin Titanium Dioxide Tartaric Acid Polysorbate 80 Sorbitan Monooleate Edetate Disodium Dihydroxyaluminum Aminoacetate Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-07-01

Description

Menthol 5%

Purpose

Topical Analgesic


Medication Information

Purpose

Topical Analgesic

Description

Menthol 5%

Uses

For temporary relief of minor aches and pains of muscles and joints associated with : ■ Simple backache ■ Arthritis ■ Strains ■ Bruises ■ Sprains

Warnings

For external use only

Safety Warning : Prior to using the product, conduct a skin patch test on your forearm to assess sensitivity and/or allergic reactions

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Do not use

■ On wounds or damaged skin

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Ask a doctor or pharmacist before use if you are allergic to any active or inactive ingredients

--------------------------------------------------------------------------------------------------------

When using this product

■ Use only as directed ■ Read and follow all directions and warnings on this label ■ Do not allow contact with the eyes and mucous membranes or rashes ■ Do not bandage tightly or apply local heat (such as heating pads) to the area of use

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Stop use and ask a doctor if

■ Condition worsens ■ Rash, itching or excessive skin irritation develops ■ Symptoms persist for more than 7 days or recur ■ Skin swells or blisters where the product was applied

--------------------------------------------------------------------------------------------------------

If pregnant or breast-feeding, ask a health professional before use

Keep out of reach of children and pets. If swallowed, get medical help or contact a Poison Control Center right away

Directions

Adult and children 12 years of age and over :

■ Clean and dry affected area ■ Peel film from patch and apply to the skin (see illustration) ■ Use 1 patch at a time and do not use for more than 12 hours

Children under 12 years of age : consult a physician

Other Information

■ Store at room temperature 68° to 77°F (20° to 25°C) ■ Store in a clean, dry place out of direct sunlight ■ Protect from excessive moisture

Inactive Ingredients

Glycerin, Propylene Glycol, Sodium Polyacrylate, Gelatin, Polyvinylpyrrolidone, Carboxymethylcellulose Sodium, Polyvinyl Alcohol, Kaolin, Titanium Oxide, Tartaric Acid, Polysorbate 80, Sorbitan Monooleate, Disodium Edetate Hydrate, Dihydroxyaluminum Aminoacetate, Water

Questions Or Comments

■ Visit us at : icure.co.kr/en ■ Contact us : [email protected]

Active Ingredients (in Each Patch)

Menthol 5%

Package Label.principal Display Panel

Keep Out of Reach of Children and Pets

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


Structured Label Content

Uses

For temporary relief of minor aches and pains of muscles and joints associated with : ■ Simple backache ■ Arthritis ■ Strains ■ Bruises ■ Sprains

Purpose (PURPOSE)

Topical Analgesic

Warnings (WARNINGS)

For external use only

Safety Warning : Prior to using the product, conduct a skin patch test on your forearm to assess sensitivity and/or allergic reactions

--------------------------------------------------------------------------------------------------------

Do not use

■ On wounds or damaged skin

--------------------------------------------------------------------------------------------------------

Ask a doctor or pharmacist before use if you are allergic to any active or inactive ingredients

--------------------------------------------------------------------------------------------------------

When using this product

■ Use only as directed ■ Read and follow all directions and warnings on this label ■ Do not allow contact with the eyes and mucous membranes or rashes ■ Do not bandage tightly or apply local heat (such as heating pads) to the area of use

--------------------------------------------------------------------------------------------------------

Stop use and ask a doctor if

■ Condition worsens ■ Rash, itching or excessive skin irritation develops ■ Symptoms persist for more than 7 days or recur ■ Skin swells or blisters where the product was applied

--------------------------------------------------------------------------------------------------------

If pregnant or breast-feeding, ask a health professional before use

Keep out of reach of children and pets. If swallowed, get medical help or contact a Poison Control Center right away

Directions

Adult and children 12 years of age and over :

■ Clean and dry affected area ■ Peel film from patch and apply to the skin (see illustration) ■ Use 1 patch at a time and do not use for more than 12 hours

Children under 12 years of age : consult a physician

Other Information

■ Store at room temperature 68° to 77°F (20° to 25°C) ■ Store in a clean, dry place out of direct sunlight ■ Protect from excessive moisture

Inactive Ingredients (INACTIVE INGREDIENTS)

Glycerin, Propylene Glycol, Sodium Polyacrylate, Gelatin, Polyvinylpyrrolidone, Carboxymethylcellulose Sodium, Polyvinyl Alcohol, Kaolin, Titanium Oxide, Tartaric Acid, Polysorbate 80, Sorbitan Monooleate, Disodium Edetate Hydrate, Dihydroxyaluminum Aminoacetate, Water

Questions Or Comments (Questions or Comments)

■ Visit us at : icure.co.kr/en ■ Contact us : [email protected]

Active Ingredients (in Each Patch) (Active Ingredients (in each patch))

Menthol 5%

Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)

Keep Out of Reach of Children and Pets (Keep out of reach of children and pets)

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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)