FDA Label for Quality Choice Tolnaftate Antifungal

View Indications, Usage & Precautions

Quality Choice Tolnaftate Antifungal Product Label

The following document was submitted to the FDA by the labeler of this product Chain Drug Marketing Association Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Otc - Active Ingredient



Active ingredient                                                                  Purpose

Tolnaftate 1%....................................................................Antifungal


Otc - Purpose



Uses

  • clinically proven to cure most athlete's foot (tinea pedis), jock itch (tinea cruris) and ringworm (tinea corporis)
  • helps prevent most athlete's foot recurring when used daily
  • effectively soothes and relieves itching associated with jock itch, scaly skin between the toes and burning feet

Warnings



Warnings For external use only


Otc - When Using



When using this product avoid contact with the eyes


Otc - Stop Use



Stop use and ask a doctor if

  • irritation occurs
  • there is no improvement within 4 weeks

Otc - Do Not Use



Do not use on children under 2 years of age except under the advice and supervision of a doctor.


Otc - 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.


Indications & Usage



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 space between the toes, wear well-fitting, ventilated shoes and change shoes and socks at least one daily
  • use daily for 4 weeks; if condition persists longer, ask a doctor
  • 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 2° and 30° C (36° and 86° F)
  • Lot No. and Exp. Date:see box or see crimp of tube

Inactive Ingredient



Inactive ingredients propylene glycol, liquid paraffin, stearyl alcohol, cetyl alcohol, sorbitan monostearate, polyoxyethylene cetylether, purified water, methylparaben, propylparaben


Dosage & Administration



Distributed By Quality Choice

Novi, Mi 48376-0995

Made in Korea


Package Label.Principal Display Panel




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