Terramed Just Think Comfort Armor Antifungal Medicated Soap
FDA Label NDC 83004-017

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 Armor Antifungal Medicated (NDC 83004-017). 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, product label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Tolnaftate 1%

Purpose

Antifungal

Uses

● Proven clinically effective in the treatment of most athlete's foot (tinea pedis), ringworm (tinea corporis) and jock itch (tinea cruris).
● For effective relief of itching, burning and cracking skin.

Warnings

For external use only

When using this productavoid contact with the eye

Stop use and ask a doctor ifirritation occurs or if there is no improvement within 2 weeks for jock itch or within 4 weeks for athlete's foot and ringworm.

Do Not use onchildren under 2 under of age except under the advice and supervision of a doctor.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

● Wash affected area well and let product sit 1-2 minutes before rinsing.
● 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

Sodium Palmate, Sodium Palm Kernelate, Water, Glycerin, Sodium Gluconate, Eucalyptus Globulus Leaf Oil, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Palm Acid, Sodium Chloride, Palm Kernel Acid, Charcoal Powder

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