Kendall Antifungal
FDA Label NDC 28851-692

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Covidien Inc. for the product Kendall Antifungal (NDC 28851-692). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, dosage & administration, other, inactive ingredient, otc - questions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active Ingredient

Miconazole nitrate 2%

Otc - Purpose

Purpose

Antifungal

Indications & Usage

Uses

  • for the treatment of 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, and chafing associated with jock itch.

Warnings

Warnings

Do not use on children under two years old unless directed by a doctor.

For external use only.

When using this product 
  • do not get into eyes
    • For the treatment of athlete's foot and ringworm, if irritation occurs or if there is no improvement within four weeks, discontinue use and consult a doctor.


    For the treatment of jock itch,     if irritation occurs or if there is no improvement within two weeks, discontinue use and consult a doctor.

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


Dosage & Administration

Directions  Clean the affected area and dry thoroughly.  Apply a thin layer of the product over the 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 and change shoes and socks at least once daily.  For athlete's foot and ringworm, use daily for four weeks; for jock itch, use daily for two weeks.  If condition persists longer, consult a doctor.  This product is not effective on the scalp or nails.

Other

Other Information

  • protect from freezing
  • avoid excessive heat

Inactive Ingredient

Inactive ingredients

Water, mineral oil propylene glycol, sorbitane stearate, cetyl alcohol, isopropyl palmitate, simmondsia chinensis (jojoba) seed oil, sodium lactate, polysorbate 60, dimethicone, butyrospermum parkii (shea butter), decylene glycol, xanthan gum, retinyl palmitate, tocopheryl acetate, cetyl hydroxyethylcellulose, methylparaben, propylparaben, diazolidinyl urea

Otc - Questions

Questions or comments?  1-800-962-9888

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Image of Antifungal Cream 4 oz Label

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