Tinea Versicolor Treatment Cream
Initial Drug Listing - Tinea Versicolor Treatment Cream
32d71d7e-3c78-6b63-e063-6294a90adaed
HUMAN OTC DRUG LABEL
Apr 15, 2025
Beautivity LLC
DUNS: 096573788
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Clotrimazole
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (9)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
INDICATIONS & USAGE SECTION
Helps relieve & prevent itching, burning, cracking, and scaling associated with tinea nersicolor infections.
OTC - ACTIVE INGREDIENT SECTION
Clotrimazole 1%
OTC - PURPOSE SECTION
Antifungal
WARNINGS SECTION
For External Use Only
it on children under 2 years of age unless directed by a doctor.
avoid contact with eyes, if contact occurs, rinse the eyes very thoroughly with water.
Stop Using and Ask a Physician if irritation occurs or there is no improvement within 4 weeks.
keep out of the reach of young children.
DOSAGE & ADMINISTRATION SECTION
- 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 SECTION
Store at room temperature. Protect from excessive heat (above 104ºF/40ºC)
INACTIVE INGREDIENT SECTION
Purified Water, Camphor, Gentiana Lutea Root, Propylene Glycol, Glycerin, Methylparaben, Triethanolamine, Peppermint Oil
OTC - QUESTIONS SECTION
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