FDA Label for Triple Antifungal

View Indications, Usage & Precautions

Triple Antifungal Product Label

The following document was submitted to the FDA by the labeler of this product Advantice Health, 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 Advantice Health, LLC
Cedar Knolls, NJ 07927


Active Ingredient



Miconazole nitrate 2%


Purpose



Antifungal


Uses



  • For the treatment of superficial skin infections caused by yeast (Candida albicans)
  • Relieves discomfort, irrit.ation, redness and chafing associated with jock itch
  • Cures most jock itch (tinea cruris)

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 2 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



  • Clean affected area and dry thoroughly
  • Apply a thin layer of product over affected area twice daily (morning and night) or as directed by a doctor
  • Supervise children in the use of this product
  • Use daily for 2 weeks; If condition persists longer, consult a doctor
  • This product is not effective on the scalp or nails

Other Information



Store at room temperature 15°– 30°C (59°– 86°F)


Inactive Ingredients



White petrolatum, zinc oxide, corn starch, anhydrous lanolin, stearyl alcohol, beeswax, cholesterol.


Questions?



1-800-345-0032


Principal Display Panel - 56.7 G Tube Carton



Triple Paste AF®

2% MICONAZOLE NITRATE ANTIFUNGAL OINTMENT

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