Label: TOLNAFTATE cream
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Contains inactivated NDC Code(s)
NDC Code(s): 51852-102-01 - Packager: LIFElabs, a Division of Atico International, USA, INC.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated August 23, 2010
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- Tolnaftate
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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
- INDICATIONS & USAGE
- STOP USE
- DO NOT USE
- KEEP OUT OF REACH OF CHILDREN
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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
- INACTIVE INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
TOLNAFTATE
tolnaftate creamProduct 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)