DERMAN ANTIFUNGAL POWDER TOLNAFTATE- tolnaftate aerosol, powder

Derman Antifungal Powder Tolnaftate by

Drug Labeling and Warnings

Derman Antifungal Powder Tolnaftate by is a Otc medication manufactured, distributed, or labeled by Taisho Pharmaceutical California 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:

Clinically proven to prevent most athlete's foot with daily use Relieves

• Athlete's foot (tinea pedis) 
• Jock itch (tine cruris)
• Ringworm (tinea corporis)

• itching 
• cracking
• burning
• scaling

Warnings

For external use only

 Contents under pressure. Do not puncture or incinetare or store at a temperature above 120°F. Use only as directed. Intentional misuse by deliberately concentrating and inhaling aerosol products can be harmful or fatal. Do not use near flame or spark or white smoking. Flammable:

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 ask a doctor 

if irritation occurs or if there is no improvement within 4 weeks (for athlete's foot or ringworm) or within 2 weeks (for jock itch)

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
• shake can well before use: hold can about 6 inches from the area to be treated
• apply a thin layer over the affected area twice daily (morning and night), or as directed by a doctor
• supervise children in the use of this product
• use daily for 4 weeks for athlete's foot and ringworm; use daily for 2 weeks for jock itch
• to prevent most athlete's foot apply once or twice daily (morning and/or night)
• if condition persists longer, consult a doctor 
• this product is not effective on the scalp or nails
• 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

Other information

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

Inactive ingredients

BHT, Corn Starch, Isobutane, Kaolin, PPG-12-Buteth-16, SD Alcohol 40-B

Package Labeling:

INGREDIENTS AND APPEARANCE

DERMAN ANTIFUNGAL POWDER TOLNAFTATE 
tolnaftate aerosol, powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81929-001
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 g

Inactive Ingredients
Ingredient Name	Strength
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
STARCH, CORN (UNII: O8232NY3SJ)
ISOBUTANE (UNII: BXR49TP611)
KAOLIN (UNII: 24H4NWX5CO)
PPG-12-BUTETH-16 (UNII: 58CG7042J1)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81929-001-01	1 in 1 BOX	05/01/2022	11/30/2028
1		130 g in 1 CAN; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M005	05/01/2022	11/30/2028

Labeler - Taisho Pharmaceutical California Inc. (603827635)