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  5. Label Information: Kendall Antifungal

FDA Label for Kendall Antifungal

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. OTC - PURPOSE
    3. INDICATIONS & USAGE
    4. WARNINGS
    5. DOSAGE & ADMINISTRATION
    6. OTHER
    7. INACTIVE INGREDIENT
    8. OTC - QUESTIONS
    9. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Kendall Antifungal Product Label

The following document was submitted to the FDA by the labeler of this product Covidien Inc.. 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.

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


Package Label.Principal Display Panel




Image of Antifungal Cream 4 oz Label


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