FDA Label for Sunmark Miconazole Nitrate Antifungal

View Indications, Usage & Precautions

Sunmark Miconazole Nitrate Antifungal 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 One Post Street
San Francisco, CA 94104


Active Ingredient



Miconazole nitrate 2%


Purpose



Antifungal


Uses



  • cures most athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis)
  • for effective relief of
    • itching
    • scaling
    • cracking
    • burning
    • redness
    • soreness
    • irritation
    • discomfort

Warnings



For external use only


Ask A Doctor Before Use



  • on children under 2 years of age

When Using This Product



  • avoid contact with eyes

Stop Use And Ask A Doctor If



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



This product is not effective on the scalp or nails.

For athlete's foot and ringworm: use daily for 4 weeks. For jock itch: use daily for 2 weeks.

  • 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 spaces between the toes; wear well-fitting, ventilated shoes; change shoes and socks at least once daily


Other Information



  • To open: unscrew cap, use pointed end on cap to puncture seal
  • store at room temperature
  • see carton or tube crimp for lot number and expiration date

Inactive Ingredients



apricot kernel oil, benzoic acid, BHT, glycol stearate, mineral oil, PEG-6, PEG-6-32 stearate, purified water


Questions?



Call 1-866-923-4914


Principal Display Panel - 30 G Tube Carton



sunmark

antifungal cream

Miconazole Nitrate 2%
CURES MOST ATHLETE'S FOOT

NET WT 1 OZ (30 g)


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