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  5. Label Information: Tolnaftate

FDA Label for Tolnaftate

View Indications, Usage & Precautions

Table of Contents

    1. TOLNAFTATE
    2. OTC - PURPOSE
    3. WARNINGS
    4. INDICATIONS & USAGE
    5. OTC - STOP USE
    6. OTC - DO NOT USE
    7. OTC - KEEP OUT OF REACH OF CHILDREN
    8. DOSAGE & ADMINISTRATION
    9. STORAGE AND HANDLING
    10. INACTIVE INGREDIENT
    11. OTC - QUESTIONS
    12. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Tolnaftate Product Label

The following document was submitted to the FDA by the labeler of this product Lifelabs, A Division Of Atico International, Usa, 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.

Tolnaftate



Active ingredient

Tolnaftate 1%


Otc - 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


Otc - 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)

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


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


Otc - Questions



Questions?

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


Package Label.Principal Display Panel






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