Otc - Active Ingredient
PURPOSE.Antifungal
ACTIVE INGREDIENT (IN EACH BAR)Clotrimazole 1%.
Tea Tree Antifungal Soap
FDA Label NDC 87800-0001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Hong Kong Unordered Trading Co., Limited for the product Tea Tree Antifungal (NDC 87800-0001). 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, otc - keep out of reach of children, warnings, dosage & administration, indications & usage, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
cures most athlete's foot (tinea pedis), jock itch
(tinea cruris), and ringworm(tinea corporis)
relieves itching, burning, cracking, and discomfort
associated with these conditions
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.If swallowed, get medical help or contact aPoison Control Center right away.
Warnings
WARNINGS
For external use only.
Dosage & Administration
if irritation occursthere is no improvement within 4 weeks (for athlete'sfoot and ringworm) or 2 weeks (for jock itch).
Indications & Usage
Clean the affected area and drythoroughly.Apply a thin layer of the product overthe affected area twice daily (morningand night) or as directed by a doctor.Supervise children in the use of this
product.For athlete's foot, pay special attentionto spaces between the toes; wear well-fitting, ventilated shoes, and changeshoes and socks at least once daily.- For athlete's foot and ringworm, usedaily for 4 weeks.For jock itch, use daily for 2 weeks.If condition persists longer, consult adoctor.
This product is not effective on the
scalp or nails.
Inactive Ingredient
INACTIVE INGREDIENTSSORBITOL, PROPYLENE GLYCOL,SODIUM STEARATE,GLYCERIN, SODIUMLAURATE, SODIUM LAURETH SULFATE,SUCROSE, COCAMIDOPROPYL BETAINE,PEG-8, WATER, OLEA EUROPAEA(OLIVE)FRUIT OIL, SIMMONDSIA CHINENSIS(OJOBA) SEED OIL, BUTYROSPERMUMPARKII (SHEA) BUTTER, FRAGRANCE,MELALEUCA ALTERNIFOLIA (TEA TREE)LEAF OIL, MENTHOLUM, SODIUMCHLORIDE
Package Label.Principal Display Panel
Labeling (87800 001 01)
* Please review the disclaimer below.
