Otc - Active Ingredient
Clotrimazole 1%
Clear Root Labs Antifungal Treatment Ointment
FDA Label NDC 24909-053
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Aidance Scientific, Inc., Dba Aidance Skincare & Topicals for the product Clear Root Labs Antifungal Treatment (NDC 24909-053). 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 - keep out of reach of children, dosage & administration, inactive ingredient, otc - questions, 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
USES: Proven clinically effective in the treatment of athlete’s foot (tinea pedis), jock itch
(tinea cruris), ringworm (tinea corporis). For effective relief of itching, irritation, redness,
scaling, cracking, burning, soreness, and discomfort which can accompany these conditions.
Warnings
WARNINGS: For external use only. Do not use on children under two years of age unless
directed by a physician. Avoid contact with the eyes. If irritation occurs or if there is no
improvement within 2 weeks, discontinue use and consult a physician.
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
DIRECTIONS: Wash and dry affected skin. Apply a layer of ointment over affected area
twice daily or as directed by a doctor. Supervise children in the use of this product. Store at
room temperature. May temporarily (washable) discolor skin, nails, and fabrics in sunlight.
Inactive Ingredient
INACTIVE INGREDIENTS: beeswax, coconut oil (organic), cottonseed oil, jojoba oil,
magnesium oxide, MCT oil, peppermint oil, sage oil, silver stearate, tea tree oil, vegetable
stearic acid (naturally sourced), witch hazel, zinc oxide
Otc - Questions
QUESTIONS? (401) 216-8075
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