Otc - Active Ingredient
ACTIVE INGREDIENT(IN EACH BAR)Tolnaftate 1%.
PURPOSE Antifungal
Activ-charcoal Antifungal Soap
FDA Label NDC 87800-0002
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 Activ-charcoal Antifungal (NDC 87800-0002). 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
USES cures most athlete's foot (tinea pedis) and
ringworm (tinea corporis)
effectively relieves itching, burning, cracking, and
chafing associated with athlete's foot and jock itch
prevents the recurrence of athlete's foot (tinea pedis)
when used daily
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
WARNINGSFor external use only.
Dosage & Administration
For athlete's foot and ringworm, use
daily for 4 weeks.
For jock itch, use daily for 2 weeks.
If condition persists longer, consult a
doctor.
Indications & Usage
DIRECTIONSClean 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, SODIUM CHLORIDE,CHARCOAL POWDER
Package Label.Principal Display Panel
Labeling (87800 002 01)
* Please review the disclaimer below.
