FDA Label for Silka Ringworm

View Indications, Usage & Precautions

Silka Ringworm Product Label

The following document was submitted to the FDA by the labeler of this product Genomma Lab 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.

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Drug Facts

Distributed by:
Genomma Lab USA Inc., Houston, TX, 77027


Active Ingredient



Clotrimazole 1%


Purpose



Antifungal


Uses



  • cures most ringworm
  • relieves itching, redness, irritation and discomfort which accompany this condition

Warnings



For external use only


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

Otc - Do Not Use



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


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
  • use daily for 4 weeks
  • if condition persists longer, ask a doctor
  • this product is not effective on the scalp or nails

Other Information



  • To open: unscrew cap, use the pointed end of cap to puncture seal.
  • store between 20°- 25°C (68° - 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 1 877 99 GENOM (43666)


Principal Display Panel - 14.2 G Tube Carton



SILKA®
Clotrimazole Cream USP, 1%
ANTIFUNGAL CREAM

CURES MOST RINGWORM

NET WT 0.5 oz (14.2 g)


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