FDA Label for Miconazole Nitrate

View Indications, Usage & Precautions

Miconazole Nitrate 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



Miconazole nitrate USP 2%


Purpose



Antifungal


Uses



  • proven clinically effective in the treatment of most athlete's foot, jock itch and ringworm
  • for effective relief of itching, scaling, burning and discomfort that can accompany these conditions

Warnings



For external use only


Otc - Do Not Use



Do not use on children less than 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
  • condition persists
  • there is no improvement of athlete's foot or ringworm within 4 weeks or jock itch within 2 weeks

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. (1-800-222-1222)


Directions



  • clean the affected area and dry thoroughly
  • apply a thin layer of the product 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 the 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
  • 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 on cap to puncture seal
  • store at 20° to 25°C (68° to 77°F)
  • see carton flap or tube crimp for lot number and expiration date

Inactive Ingredients



benzoic acid (0.20%) as a preservative, butylated hydroxytoluene, mineral oil, oleoyl polyoxylglyceride, PEG-6-32 stearate/glycol stearate, and purified water


Questions?



call 833-358-6431


Principal Display Panel - 30 G Tube Carton



Foster & Thrive™

Antifungal Cream

Miconazole Nitrate Cream USP, 2%
ANTIFUNGAL

NET WT 1 OZ (30 g)


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