Active Ingredient
Tolnaftate 1.0%
Terramed Just Think Comfort Armor Antifungal Body Wash Tea Tree Gel
FDA Label NDC 83004-032
7 label sections · Submitted to the FDA by Rida Llc · 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 Armor Antifungal Body Wash Tea Tree (NDC 83004-032). 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, warning, directions, inactive ingredients, 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, and scaling which accompany these conditions
Warning
• For external use only.
Do not use
• on children under 2 years of age unless directed by a doctor
When using this product
• avoid contact with eyes
• if contact occurs, rinse thoroughly with water
Stop use and ask a doctor if
• irritation occurs
• there is no improvement within 2 weeks for jock itch or within 4 weeks for athlete's foot and ringworm
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- Make sure to dry affected area thoroughly.
- 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.
- Use 1-2 times daily. Use daily for 4 weeks; if condition persists longer, ask a doctor.
- This product is not effective on the scalp or nails.
Inactive Ingredients
TETRASODIUM GLUTAMATE DIACETATE, EUCALYPTUS OIL, WATER, SODIUM GLUCONATE, SODIUM PALM KERNELATE, GLYCERIN, MELALEUCA ALTERNIFOLIA LEAF, SODIUM CHLORIDE, ACTIVATED CHARCOAL, SODIUM COCOATE, SODIUM PALMATE, SODIUM LAURETH SULFATE, SODIUM LAURYL SULFATE, SODIUM COCOATE
Product Label
Image Description (Updated Image)
* Please review the disclaimer below.
