Toplast Cool And Hot Menthol 1.25percent Plus Capsaicin 0.025percent
FDA Label NDC 73279-0016

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Icure Pharmaceutical Inc, Wanju Factory for the product Toplast Cool And Hot Menthol 1.25percent Plus Capsaicin 0.025percent (NDC 73279-0016). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients, inactive ingredients, purpose, warnings, keep out of reach of children and pets, uses, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Menthol 1.25%
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

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