FDA Label for Toplast Cool And Hot Menthol 5percent Plus Capsaicin 0.025percent
View Indications, Usage & Precautions
Toplast Cool And Hot Menthol 5percent Plus Capsaicin 0.025percent Product Label
The following document was submitted to the FDA by the labeler of this product Icure Pharmaceutical Inc, Wanju Factory. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredients
Menthol 5%
Capsicum extract 0.025% as Capsaicin
Inactive Ingredients
Glycerin, Propylene Glycol, Sodium Polyacrylate, Gelatin, Polyvinylpyrrolidone, Carboxymethylcellulose Sodium, Polyvinyl Alcohol, Kaolin, Titanium Oxide, Tartaric Acid, Disodium Edetate Hydrate, Polysorbate 80, Sorbitan Monooleate, Dihydroxyaluminum Aminoacetate, Water
Purpose
Topical Analgesic
Warnings
For external use only
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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
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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 ■ Discontinue use at least 1 hour before a bath or shower ■ Do not use immediately after a bath or shower
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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 reoccur within a few days interval
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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
Uses
For temporary relief of minor aches and pains of muscles and joints associated with : ■ Simple backache ■ Arthritis ■ Strains ■ Bruises ■ Sprains
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) ■ Apply to affected area not more than 3 to 4 times daily ■ Suggested duration of use for patch is upto 8 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
Questions Or Comments
■ Visit us at : icure.co.kr/en ■ Contact us : [email protected]
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