FDA Label for Leader Clotrimazole Anti-fungal

View Indications, Usage & Precautions

Leader Clotrimazole Anti-fungal Product Label

The following document was submitted to the FDA by the labeler of this product Cardinal Health. 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

Clotrimazole 1%..................................................................Antifungal


Otc - Purpose



Uses

  • cures most athletes foot, jock itch, and ringworms
  • relieves itching, burning, cracking, scaling and discomfort which accompany these conditions

Warnings



Warnings For external use only.


Otc - When Using



When using this product avoid contact with the eyes


Otc - Do Not Use



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


Otc - Stop Use



Stop use and ask a doctor if

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

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 spaces between the toes, wear well-fitting, ventilated shoes and change shoes and socks at least once a day
  • for athlete's foot and ringworm use daily
  • this product is not effective on the scalp or nails

Storage And Handling



Other information

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

Inactive Ingredient



Inactive ingredients benzyl alcohol, isopropyl myristate, liquid paraffin, polysorbate 60, propylene glycol, purified water, sorbitan monostearate, stearic acid, stearyl alcohol


Dosage & Administration



Distributed By Cardinal Health

Dublin, Ohio 73017

Made in Korea


Package Label.Principal Display Panel




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