VILLIMED ANTIFUNGAL- tolnaftate liquid

Villimed Antifungal by

Drug Labeling and Warnings

Villimed Antifungal by is a Otc medication manufactured, distributed, or labeled by Extremity Healthcare Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient:

Tolnaftate 1%

Purpose

Antifungal

Uses

• Proven clinically effective in the treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris) and ringworm (tinea corporis)
• Helps prevent most athlete's foot with daily use
• For effective relief of itching, burning and cracking

Warnings

• For external use only

Do not use

on children under 2 years of age except under the supervision of a doctor

When using this product avoid contact with the eyes

Stop use and ask a doctor if:

• Irritation occurs
• There is no improvement within 4 weeks

Keep out of reach of children.

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

Directions

• Wash affected area well, and let product sit for 1-2 minutes before rinsing.
• Make sure to dry affected area thoroughly.
• Supervise children in the use of this product
• For athlete's foot: pay special attention to the spaces between the toes; wear well-fitting, ventilated shoes and change shoes and socks at least once daily
• Use 1-2 times daily.
• Use daily for 4 weeks; if condition persists longer, ask a doctor
• This product is not effective on the scalp or nails 

Inactive ingredients:

Butylhydroxytoluene (BHT), Carthamus Tinctorius (Safflower) Seed Oil, Oryza Sativa (Rice) Bran Oil, Prunus Armenicaca (Apricot) Kernel Oil, Sesamum Indicum (Sesame) Seed Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Tocopheryl Acetate (Vitamin E).

Other Information

Store between 20° to 30°C (68° to 86°F)

Package Labeling:

INGREDIENTS AND APPEARANCE

VILLIMED ANTIFUNGAL 
tolnaftate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71129-772
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV)	TOLNAFTATE	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
SAFFLOWER OIL (UNII: 65UEH262IS)
RICE BRAN OIL (UNII: LZO6K1506A)
APRICOT (UNII: 269CJD5GZ9)
SESAME SEED (UNII: 7Y1255HVXR)
JOJOBA OIL (UNII: 724GKU717M)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71129-772-15	1 in 1 BOX	12/20/2016
1		15 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	12/20/2016

Labeler - Extremity Healthcare Inc (793823683)