Otc - Active Ingredient
coltrimazole 1%
Tinea Versicolor Treatment Bar Soap
FDA Label NDC 85398-003
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 Bar (NDC 85398-003). 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 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 poison control center right away.
Dosage & Administration
- Wash the affected area thoroughly and allow the product to sit for 1-2 minutes before rinsing.
- Ensure the affected area is dried completely.
- Apply 1-2 times daily for 4 weeks.
- This product is not effective for use on the scalp or nails.
Inactive Ingredient
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
Storage And Handling
Store at room temperature. Protect from excessive heat (above 104°F / 40°C)
Otc - Questions
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