Otc - Active Ingredient
Clotrimazole 1%
Terthon Clotrimazole 1% Antifungal Cream
FDA Label NDC 85849-010
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Solalia Llc for the product Terthon Clotrimazole 1% Antifungal Cream (NDC 85849-010). 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 - when using, otc - do not use, 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
Cures athlete's foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis). Relieves the itching, irritation, redness, scaling and discomfort which can accompany these conditions.
Warnings
For external use only
Otc - When Using
Avoid contact with eyes.
Otc - Do Not Use
on children under 2 years of age unless directed by a doctor.
Otc - Stop Use
If irritation occurs or if there is no improvement within 4 weeks (for athlete's foot or ringworm) or within 2 weeks (for jock itch), discontinue use and consult a doctor.
Otc - Keep Out Of Reach Of Children
Keep out of the reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center right away.
Dosage & Administration
• Wash the affected area and dry thoroughly.
• Apply a thin layer over affected area twice daily (morning and night), or as directed by a doctor.
• Supervise children in the use of this product.
• For athlete's foot, pay special attention to the spaces between the toes; wear well-fitting ventilated shoes, and change shoes and socks at least once daily.
• For athlete's foot and ringworm, use daily for 4 weeks. For jock itch, use daily for 2 weeks.
• If conditions persists longer, consult a doctor.
• This product is not effective on the scalp or nails.
Other Safety Information
• Store at controlled room temperature 15°–30°C (59°–86°F).
• Close cap tightly after use.
Inactive Ingredient
Aqua, Cetostearyl Alcohol, Caprylic/Capric Triglyceride, Glycerin, Glyceryl Stearate, Pentylene Glycol, Simmondsia Chinensis (Jojoba) Seed Oil, Phenoxyethanol, Ethylhexylglycerin, Camphor, Carbomer, Peppermint Oil, Gentiana Extract, Triethanolamine, Sodium Citrate
Otc - Questions
Contact us at [email protected]
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