Otc - Active Ingredient
Clotrimazole 1%
Tinea Versicolor Treatment Cream
FDA Label NDC 85398-002
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Beautivity Llc for the product Tinea Versicolor Treatment Cream (NDC 85398-002). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Antifungal
Indications & Usage
Helps relieve & prevent itching, burning, cracking, and scaling associated with tinea nersicolor infections.
Warnings
For External Use Only
Otc - Do Not Use
it on children under 2 years of age unless directed by a doctor.
Otc - When Using
avoid contact with eyes, if contact occurs, rinse the eyes very thoroughly with water.
Otc - Stop Use
Stop Using and Ask a Physician if irritation occurs or there is no improvement within 4 weeks.
Otc - Keep Out Of Reach Of Children
keep out of the reach of young children.
Dosage & Administration
- Wash the affected area and dry thoroughly.
- Apply a thin layer over the affected area twice daily (morning and night), or as directed by a doctor, supervise children in the use of the product.
- If the condition persists longer, consult a doctor.
Storage And Handling
Store at room temperature. Protect from excessive heat (above 104°F/40°C)
Inactive Ingredient
Purified Water, Camphor, Gentiana Lutea Root, Propylene Glycol, Glycerin, Methylparaben, Triethanolamine, Peppermint Oil
Otc - Questions
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