FDA Label for Smart Sense Tolnaftate Antifungal

View Indications, Usage & Precautions

Smart Sense Tolnaftate Antifungal Product Label

The following document was submitted to the FDA by the labeler of this product Kmart Corporation. 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

  • proved 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

Warnings



Warnings

For external use only


Otc - Ask Doctor



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 og 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 Poision Control Center right away. (1-800-222-1222) 


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 spaces between the toes, wear well-fitting, ventilated shoes and chage 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

Lot No. & Exp. Date: see box or see crimp of the tube. Store between 20° to 25°C (68° to 77°F)


Inactive Ingredient



Inactive ingredients butylated hydroxytoluene, cetanol, ceteth-20, liquid paraffin, methylparaben, propylene glycol, propylparaben, purified water, sorbitan monostearate, stearyl alcohol


Dosage & Administration



DISTRIBUTED BY:

Kmart Corporation

Hoffman Estates, IL 60179

Made in Korea


Package Label.Principal Display Panel




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