FDA Label for Tinea Versicolor Treatment Kit
View Indications, Usage & Precautions
Tinea Versicolor Treatment Kit Product Label
The following document was submitted to the FDA by the labeler of this product Beautivity Llc. 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.
Otc - Active Ingredient
Cream: Clotrimazole 1%
Soap bar: Clotrimazole 1%
Otc - Purpose
Antifungal
Indications & Usage
Helps relieve and prevent itching, burning, cracking, and scaling associated with tinea versicolor infections.
Warnings
For external use only
Otc - Do Not Use
Do not use on children under 2 years of age unless directed by a doctor.
Otc - When Using
When using this product avoid contact with eyes, If contact occurs, rinse thoroughly with water.
Otc - Stop Use
Stop use and ask doctor if irritation occurs or if there is no improvement within 2 weeks.
Otc - Keep Out Of Reach Of Children
keep out of reach of children. If swallowed, get medical help or contact a Posion Control enter right away.
Dosage & Administration
Wash the affected area & dry thoroughly.
Apply a thin layer over affected area twice daily (morning and night).
Supervise children in the use of this produt.
Use daily for 2 weeks.
Inactive Ingredient
Cream: Purified Water, Camphor, Gentiana Lutea Root, Propylene Glycol, Glycerin, Methylparaben, Triethanolamine, Peppermint Oil
Soap Bar: Melaleuca Alternifolia (Tea Tree) Leaf Oil, Water, Sorbitol, Elaeis Guineensis (Palm) Oil, Cocos Nucifera (Coconut) Oil, Olea Europaea (Olive) Fruit Oil, Propylene Glycol, Glycerin, Stearic Acid, Lauric Acid, Myristic Acid, Sodium Myristate, Sodium Glutamate, Sodium Hydroxide, Sodium Dodecylbenzenesulfonate, Sulfur, Hamamelis Virginiana Root Bark, Ceramide NP
Storage And Handling
Store at room temperature. Protect from excessive heat (above 104°F / 40°C)
Otc - Questions
visit us at www.hermonhealth.com
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