DERMAN ANTIFUNGAL CREAM- tolnaftate cream

Derman antifungal cream by

Drug Labeling and Warnings

Derman antifungal cream 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

• cures most athlete's foot, jock itch, and ringworm 
• relieves itching, burning, cracking, scaling, redness, soreness, irritation and discomfort

Warnings

Do not use

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

For external use only.

Avoid contact with eyes.

Stop use and ask a doctor if 

• irritation occurs
• there is no improvement within 4 weeks for athlete's foot and ringworm or 2 weeks for jock itch

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away: 800-222-1222.

Directions

• wash affected area and dry thoroughly
• apply 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; for jock itch, use daily for 2 weeks 
• if condition persists longer, consult a doctor 
• this product is not effective on the scalp or nails

Other information

store at 15 to 30°C (59° to 86°F)

DO NOT USE IF SEAL ON TUBE IS PUNCTURED OR MISSING. Tamper Evident:

Inactive ingredients

ceteth-20, cetyl alcohol, chlorocresol, mineral oil, monobasic sodium phosphate, petrolatum, propylene glycol, purified water, stearyl alcohol

Package Labeling:25g

Package Labeling:50g

INGREDIENTS AND APPEARANCE

DERMAN ANTIFUNGAL CREAM 
tolnaftate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81929-004
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
CETETH-20 (UNII: I835H2IHHX)
CETYL ALCOHOL (UNII: 936JST6JCN)
CHLOROCRESOL (UNII: 36W53O7109)
MINERAL OIL (UNII: T5L8T28FGP)
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM (UNII: 3980JIH2SW)
PETROLATUM (UNII: 4T6H12BN9U)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81929-004-02	1 in 1 CARTON	07/01/2022	10/28/2027
1		25 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 81929-004-01	1 in 1 CARTON	07/01/2022	05/24/2027
2		50 g in 1 TUBE; 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	07/01/2022	10/28/2027

Labeler - Taisho Pharmaceutical California Inc. (603827635)