SPL UNCLASSIFIED SECTION
Drug Facts
Active ingredient
Miconazole nitrate 2% USP
Purpose
Antifungal
Uses
- •cures most athlete's foot (tinea pedis) and ringworm (tinea corporis)
- •for effective relief of itchy, scaly skin between the toes
Warnings
For external use only
Flammable:
Do not use while smoking or near heat or flame.
Do not use
on children under 2 years of age unless directed by a doctor.
When using this product
- •avoid contact with the eyes.
- •if irritation occurs or if there is no improvement within 4 weeks, discontinue use and consult a doctor.
Keep out of reach of children.
If swallowed, 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 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
- •this product is not effective on scalp or nails.
Other information
- •store at controlled room temperature 15-30oC (59-86oF)
Inactive ingredients
acetic acid, benzyl alcohol, isopropyl alcohol (30%), laureth-4, water
Fungoid Tincture – 1 fl. oz. (29.57 mL) Carton
NDC 0884-0293-01
PEDiNOL®
fungoid® tincture
miconazole nitrate 2%
topical antifungal
1 fl. oz. (29.57 mL)