Triple Antifungal Ointment
FDA Label NDC 16864-040

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Advantice Health, Llc for the product Triple Antifungal (NDC 16864-040). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient, purpose, uses, warnings, otc - when using, stop use and ask a doctor if, otc - do not use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

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

  • ➕Relieves burning, redness,
    irritation and discomfort
  • ➕Unique, soothing,
    water-resistant formula
  • ➕Lubricates skin to heal
    and prevent chafing

    • Help is on the way...

    Net Wt. 2 oz (56.7 g)

    Principal Display Panel (56.7 g Tube Carton)

    Principal Display Panel (56.7 g Tube Carton)

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