FDA Label for Maximum Strength Antifungal Liquid
View Indications, Usage & Precautions
Maximum Strength Antifungal Liquid Product Label
The following document was submitted to the FDA by the labeler of this product Hudson Health Llc. 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.
Active Ingredient
Tolnaftate 1% w/w
Purpose
Antifungal
Uses
- proven clinically effective in the treament of most athlete's foot (tinea pedis) and ring worm (tinea corporis).
- prevents the recurrence of most athlete's foot with daily use
- for effective relief of itching, burning, cracking, redness and scaling,
Warnings
For external use only.
Do Not Use
on children under 2 years of age unless directed by a doctor.
When Using This Product
avoid contact with the eyes.
Stop Use And Consult A Doctor If
- irritation occurs
- there is no improvement within 4 weeks.
Keep Out Of Reach Of Children.
If accidental ingestion occurs, get medical help or contact a Poison Control Center right away.
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 doctor.
- 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 athlete's foot and ringworm, use daily for 4 weeks.
- If condition persists longer, consult a doctor.
- to prevent athlete's foot: wash the feet and dry thoroughly; apply a thin layer of the product to the feet once or twice daily (morning and/or night)
- this product is not effective on the scalp or nails.
Other Information
- SHAKE WELL BEFORE USE
- store at room temperature 15°-30°C (59° - 86°F)
- protect from freezing; if freezing occurs, warm to room temperature
- keep tightly closed when not in use.
Inactive Ingredient
WATER, GLYCERIN, SCLEROTIUM GUM, PHENOXYETHANOL, DISODIUM EDTA, ETHYLHEXYLGLYCERIN, XANTHAN GUM
Questions?
Call 1-877-237-0194
Principal Display Panel
comfort zone
maximum strength
antifungal liquid
tolnaftate 1%/antifungal
Prevents the recurrence
of most athlete's foot
with daily use
Proven clinically effective
in the treatment of fungus
on fingers, toes and skin
around nails
relieves itching, burning & scaling
with moisturizing ingredients
built-in applicator brush
SHAKE WELL BEFORE USE
1 FL. OZ.
(30 mL)
* Please review the disclaimer below.