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  5. Label Information: Silka Athletes Foot

FDA Label for Silka Athletes Foot

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENT
    3. PURPOSE
    4. USES
    5. WARNINGS
    6. OTC - DO NOT USE
    7. WHEN USING THIS PRODUCT
    8. STOP USE AND ASK A DOCTOR IF
    9. OTC - KEEP OUT OF REACH OF CHILDREN
    10. DIRECTIONS
    11. OTHER INFORMATION
    12. INACTIVE INGREDIENTS
    13. QUESTIONS?
    14. PRINCIPAL DISPLAY PANEL - 130 G CANISTER LABEL

Silka Athletes Foot Product Label

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

Other



Drug Facts

Distributed by: Genomma Lab, Houston, TX 77098


Active Ingredient



Miconazole nitrate 2%


Purpose



Antifungal


Uses



  • Clinically proven to be effective in the treatment of most athlete's foot (tinea pedis)
  • Provides effective relief of itching, cracking, burning, scaling, and discomfort.

Warnings



For external use only.

Flammable. Do not use while smoking or near heat or flame.


Otc - Do Not Use



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


When Using This Product



  • Avoid contact with eyes
  • in case of contact with eyes, flush thoroughly with water
  • Avoid applying on broken skin
  • do not inhale or ingest
  • contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120°F

Stop Use And Ask A Doctor If



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

Otc - Keep Out Of Reach Of Children



Keep out of the reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.


Directions



  • wash affected area and dry thoroughly
  • shake can well and spray 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
  • this product is not effective on the scalp or nails

Other Information



  • store between 20° to 25° (68° to 77°F)

Inactive Ingredients



Alcohol Denat., polysorbate 20, tetrafluoropropene


Questions?



1-877-994-3666 Monday to Friday, 8am to 6pm Central time.


Principal Display Panel - 130 G Canister Label



SILKA®
ATHLETE'S FOOT
POWDER SPRAY

Miconazole nitrate 2% - antifungal

CLINICALLY PROVEN TO CURE MOST
ATHLETE'S FOOT*

HELPS RELIEVE

* Please review the disclaimer below.