FDA Label for Clotrimazole 1% Athletes Foot

View Indications, Usage & Precautions

Clotrimazole 1% Athletes Foot Product Label

The following document was submitted to the FDA by the labeler of this product Strategic Sourcing Services Llc. 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.

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Drug Facts

Distributed by: McKesson Corp.,
via Strategic Sourcing Services LLC.
Memphis, TN 38141


Active Ingredient



Clotrimazole 1%


Purpose



Antifungal


Uses



  • cures most athlete's foot, jock itch and ringworm
  • relieves itching, burning, cracking, scaling and discomfort which accompany these conditions

Warnings



For external use only


Otc - Do Not Use



Do not use on children under 2 years of age unless directed by a doctor.


Otc - When Using



When using this product avoid contact with the eyes.


Stop Use And Ask A Doctor If



  • irritation occurs
  • there is no improvement within 4 weeks (for athlete's foot or 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.


Directions



  • wash affected area and dry thoroughly
  • apply a thin layer over affected area twice daily (morning and night)
  • 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, ask a doctor
  • this product is not effective on the scalp or nails

Other Information



  • TAMPER EVIDENT: DO NOT USE IF THE SEAL ON THE TUBE IS PUNCTURED OR NOT VISIBLE.
  • to open: unscrew cap, use the pointed end of cap to puncture seal.
  • store between 20° to 25°C (68° to 77°F)
  • see carton or tube crimp for lot number and expiration date

Inactive Ingredients



benzyl alcohol (1%), cetostearyl alcohol, cetyl esters wax, 2-octyldodecanol, polysorbate 60, purified water, sorbitan monostearate


Questions?



call 833-358-6431


Principal Display Panel - 30 G Tube Carton



Foster & Thrive™

Athlete's Foot Cream

Clotrimazole Cream USP, 1%
ANTIFUNGAL

NET WT 1 OZ (30 g)


* Please review the disclaimer below.