FDA Label for Homehealth Antifungal

View Indications, Usage & Precautions

Homehealth Antifungal Product Label

The following document was submitted to the FDA by the labeler of this product Home Health. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Otc - Active Ingredient



Active Ingredient                                                           Purpose

Tolnaftate 1.0%..........................................................Antifungal


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)


* Please review the disclaimer below.