Active Ingredient
Clotrimazole 10 mg (1%)
Terramed Just Think Comfort Clotrimazole Antifungal Topical Solution
FDA Label NDC 83004-042
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Rida Llc for the product Terramed Just Think Comfort Clotrimazole Antifungal Topical Solution (NDC 83004-042). 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 active ingredient, purpose, uses, warnings, directions, inactive ingredients, other information, product label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antifungal
Uses
• cures most athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis)
• relieves itching, burning, cracking, scaling and discomfort associated with these conditions
Warnings
For external use only.
Do not use
• on nails or scalp
• in or near the eyes, mouth, or nose
• for vaginal yeast infections
• on children under 2 years of age except under the advice and supervision of a doctor
When using this product
• avoid contact with the eyes
• do not bandage tightly
• use only as directed
Stop use and ask a doctor if
• irritation, redness, or swelling occurs or gets worse
• there is no improvement within 4 weeks for athlete's foot or ringworm, or 2 weeks for jock itch
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions
• adults and children 2 years of age and older:
• wash the affected area with soap and water and dry thoroughly before applying
• apply a thin layer of the product over the 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 spaces between the toes; wear well-fitting, ventilated shoes and change shoes and socks at least once daily
• use daily for 4 weeks for athlete's foot and ringworm, 2 weeks for jock itch
• if condition persists longer, consult a doctor
• children under 2 years of age: ask a doctor
Inactive Ingredients
Alcohol, Isopropyl Myristate, Polyethylene Glycol 400, Propylene Glycol, Purified Water.
Other Information
• store at 20°–25°C (68°–77°F)
• protect from excessive heat and freezing
• tightly close cap after each use
Product Label
Image Description (Image 1)
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