Tolnaftate by LIFElabs, a Division of Atico International, USA, INC. TOLNAFTATE cream

Tolnaftate by

Drug Labeling and Warnings

Tolnaftate by is a Otc medication manufactured, distributed, or labeled by LIFElabs, a Division of Atico International, USA, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Tolnaftate

Active ingredient

Tolnaftate 1%

PURPOSE

Purpose

Antifungal

Uses

• proven clinically effective in the treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis)
• proven effective in the prevention of athlete's foot with daily use
  
• for effective relief of chafing associated with jock itch
  
• soothes itchy, scaly skin between the toes and itchy, burning feet
  

WARNINGS

Warnings

For external use only

INDICATIONS & USAGE

When using this product avoid contact with the eyes

STOP USE

Stop use and ask a doctor if

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

DO NOT USE

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

Keep out of reach of children

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

DOSAGE & ADMINISTRATION

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
  

STORAGE AND HANDLING

Other information

store between 2o and 30oC (36o and 86oF)

Lot No. and Exp. Date: see box or see crimp of tube

INACTIVE INGREDIENT

Inactive ingredients

butylated hydroxytoluene, cetanol, liquid paraffin, methylparaben, polyoxyethylene cetylether, propylene glycol, propylparaben, purfied water, sorbitan monostearate, stearyl alcohol

QUESTIONS

Questions?

Call 1-800-645-3867, Mon-Fri 8:30 AM - 5:30PM.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TOLNAFTATE 
tolnaftate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51852-102
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)
Cetyl Alcohol (UNII: 936JST6JCN)
Mineral Oil (UNII: T5L8T28FGP)
Methylparaben (UNII: A2I8C7HI9T)
Ceteth-20 (UNII: I835H2IHHX)
Propylene Glycol (UNII: 6DC9Q167V3)
Propylparaben (UNII: Z8IX2SC1OH)
Water (UNII: 059QF0KO0R)
Sorbitan Monostearate (UNII: NVZ4I0H58X)
Stearyl Alcohol (UNII: 2KR89I4H1Y)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51852-102-01	1 in 1 CARTON
1		28 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	11/01/2010

Labeler - LIFElabs, a Division of Atico International, USA, INC. (073876450)