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Drug Facts
Manufactured for
The Podiatree Company, Holbrook, NY 11741
Made in U.S.A.
Clotrimazole Solution
FDA Label NDC 54633-018
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by The Podiatree Company for the product Clotrimazole (NDC 54633-018). 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 other, active ingredient, purpose, uses, warnings, 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
Active Ingredient
Clotrimazole 1%
Purpose
Antifungal
Uses
- cures most athlete's foot infections and ringworm infections
- relieve itching,burning, cracking, scaling and discomfort which can accompany these conditions
Warnings
For external use only
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 eyes thoroughly with water.
Otc - Stop Use
Stop use and ask a doctor if irritation occurs or there is no improvement within 4 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.
Directions
• wash affected area and dry thoroughly
• apply to the affected area twice daily (morning and night) or as directed by your doctor
• supervise children in the use of this product
• for athlete’s foot: pay special attention to spaces between toes; wear well-fitting, ventilated shoes and change shoes and socks at least once daily
• for athlete’s foot and ringworm infections, use daily for 4 weeks
• if condition persists longer, consult your doctor
Other Information
- Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Inactive Ingredient
polyethylene glycol
Questions?
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