Otc - Active Ingredient
Active Ingredient Purpose
Tolnaftate 1.0%..........................................................Antifungal
Homehealth Antifungal Lotion
FDA Label NDC 76020-100
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Home Health for the product Homehealth Antifungal (NDC 76020-100). 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, warnings, indications & usage, otc - stop use, otc - do not use, otc - keep out of reach of children, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Uses
- proven clinically effective in the treatment of most athlete's foot, jock itch and ringworm with daily use. - helps prevent most athlete's foot with daily use. - for effective relief of itching, burning and cracking.
Warnings
Warnings For external use only.
Indications & Usage
When using this product avoid contact with eyes.
Otc - Stop Use
Stop use and ask a doctor if irritation occurs or if there is no improvement within 2 weeks for jock itch. Stop use and ask a doctor if irritation occurs or if there is no improvement within 4 weeks for athlete's foot or ringworm.
Otc - Do Not Use
Do not use on children under 2 years of age unless directed by a doctor.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Directions
- clean the affected area and dry thoroughly; - apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a physician; - 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. - for jock itch, use daily for 2 weeks. - for athlete's foot and ringworm, use daily for 4 weeks. - if condition persists longer, consult a doctor. - this product is not effective on the scalp or nails.
Storage And Handling
Other information store in a cool, dry place.
Inactive Ingredient
Inactive Ingredients: Almond oil, aloe vera gel, calendula oil, castor oil, cetyl alcohol, citricidal (grapefruit seed extract), cocoa butter, diazolidinyl urea, lanolin oil, lavender oil, methylparaben, myrrh tincture, propylene glycol, propylparaben, rosemary oil, stearic acid, tea tree oil, thyme oil, triethanolamine, water.
Description
Antifungal Lotion provides effective relief of itching, scaling, burning, irritation and discomfort associated with athlete's foot, jock itch and ringworm. The active ingredient, Tolnaftate, combines with a soothing base of natural botanical extracts to yield a truly unique formula. You can count on Home Health to deliver the natural heath products your family deserves. No Mineral Oil, No petroleum, No Artificial Colors, No Artificial Fragrance. Carefully Manufactured for HomeHealth, Co. Ronkonxoma, NY 11779 U.S.A. 800-445-7137 www.HomeHealthUS.com 2009 Home Health B11812 03B
Package Label.Principal Display Panel
HomeHealth Natural Health Begins at Home Antifungal Lotion Tolnaftate Proven Clinicallyl Effective In the Threatment of Most Athlete's Foot, Jock Itch, Ringworm Net Wt. 4 fl. oz. (118mL)
Antifungal Lotion (Antifungallotion)
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