FDA Label for Premier Solutions Antifungal Tolnaftate Powder

View Indications, Usage & Precautions

ACTIVE INGREDIENT
PURPOSE
USES
WARNINGS
FLAMMABLE:
WHEN USING THIS PRODUCT
STOP USE AND ASK A DOCTOR IF
DO NOT USE
KEEP OUT OF REACH OF CHILDREN.
DIRECTIONS
OTHER INFORMATION
INACTIVE INGREDIENTS
QUESTIONS?
PRINCIPAL DISPLAY PANEL

Premier Solutions Antifungal Tolnaftate Powder Product Label

The following document was submitted to the FDA by the labeler of this product Premier Brands Of America Inc.. 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%

Purpose

Antifungal

Uses

proven clinically effective in the treatment of most athelete's foot (tinea pedis) and ringworm (tinea corporis)
prevents the recurrence of most athelete's foot with daily use
for effective relief of itching, cracking and burning

Warnings

For external use only.

Flammable:

Contents under pressure. Avoid Spraying eyes. do not use or store near heat or open flame. Do not puncture or incinerate. Do not store at temperature above 120°F. Keep out of reach of children. Use only as directed. Intentional misuse by deliberately concentrating and inhaling contents can be harmful or fatal.

When Using This Product

avoid contact with the eyes or mouth
use only as directed

Stop Use And Ask A Doctor If

if irritation occurs
no improvement within 4 weeks for athlete's foot and ringworm

Do Not Use

on children under 2 years of age unless directed by a doctor.

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

wash affected area and dry thoroughly
shake can well and spray a thin layer 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 conditions persist, consult a doctor
- to prevent athlete's foot: wash the feet and dry throughly; spray a thing 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
- if nozzle clogs, clean with a pin

Other Information

store between 20° and 30°C (68°F and 86°)

Inactive Ingredients

BHT, Isobutane, Kaolin, PPG-12-Buteth-16, SD Alcohol 40-B, Zea Mays (Corn) Starch

Questions?

call 1-866-964-0939

Principal Display Panel

Meijer