TOLNAFTATE D- tolnaftate cream

Tolnaftate by

Drug Labeling and Warnings

Tolnaftate by is a Otc medication manufactured, distributed, or labeled by NexMed (USA), Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Tolnaftate

Purpose

Antifungal

Uses

• Proven clinically effective in the treatment of athlete’s foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis)
• Proven effective in the prevention of athlete’s foot
• Effectively soothes and relieves itching associated with jock itch, scaly skin between the toes and burning feet

Warnings

For external use only

When using this product

avoid contact with the eyes

Stop use and ask a doctor if

• Irritation occurs
• There is no improvement within 2 weeks (for jock itch) and 4 weeks for (athlete’s foot and ringworm)

Do not use

on children under 2 years of age except under the advice and supervision of 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 over affected area twice a daily (morning and night) or as directed by a doctor
• Supervise children in the use of this product
• For athlete’s foot, pay 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 between 20⁰ and 25⁰C (68⁰ to 77⁰F)
• Lot No. and Exp. Date: see box or see crimp of tube
• Keep box for complete instructions and labeling

Inactive Ingredients

cetyl  alcohol, dodecyl-2-N N-dimethylaminopropionate hydrochloride, methylparaben, mineral oil, ceteth-10, propylene glycol, propylparaben, purified water, sorbitan monostearate, stearyl alcohol

Questions?

Call 858-222-8041, Mon-Fri, 8:30 AM - 5:30PM (PST)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TOLNAFTATE  D
tolnaftate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 40002-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Tolnaftate (UNII: 06KB629TKV) (Tolnaftate - UNII:06KB629TKV)	Tolnaftate	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
Cetyl Alcohol (UNII: 936JST6JCN)
Dodecyl-2-N,N-Dimethylaminopropionate Hydrochloride (UNII: 18F5YMF989)
Methylparaben (UNII: A2I8C7HI9T)
Mineral Oil (UNII: T5L8T28FGP)
Ceteth-10 (UNII: LF9X1PN3XJ)
Propylene Glycol (UNII: 6DC9Q167V3)
Propylparaben (UNII: Z8IX2SC1OH)
Water (UNII: 059QF0KO0R)
Sorbitan Monostearate (UNII: NVZ4I0H58X)
Stearyl Alcohol (UNII: 2KR89I4H1Y)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 40002-002-01	1 in 1 CARTON
1	NDC: 40002-002-02	28 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	08/15/2011

Labeler - NexMed (USA), Inc. (031710528)

Registrant - NexMed (USA), Inc. (031710528)