Kendall Antifungal Cream

Kendall Antifungal Cream
SPL v1
SPL
SPL Set ID 2a6a95af-3c22-44e7-a08a-c8cdfda98a21
Route
TOPICAL
Published
Effective Date 2011-04-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Miconazole (2 g)
Inactive Ingredients
Water Mineral Oil Propylene Glycol Sorbitan Monostearate Cetyl Alcohol Isopropyl Palmitate Sodium Lactate Jojoba Oil Polysorbate 60 Vitamin A Palmitate Dimethicone Shea Butter Cetyl Hydroxyethylcellulose (350000 Mw) Methylparaben 1-decene Propylparaben Diazolidinyl Urea Xanthan Gum Alpha-tocopherol Acetate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2011-04-14

Description

Active Ingredient Miconazole nitrate 2%


Medication Information

Warnings and Precautions

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.



Indications and 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.

Dosage and 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.

Description

Active Ingredient Miconazole nitrate 2%

Section 42229-5

Other Information

  • protect from freezing
  • avoid excessive heat

Section 50565-1


Section 51727-6

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

Section 51945-4


Image of Antifungal Cream 4 oz Label

Section 53413-1

Questions or comments?  1-800-962-9888

Section 55105-1

Purpose

Antifungal

Section 55106-9

Active Ingredient

Miconazole nitrate 2%


Structured Label Content

Indications and Usage (34067-9)

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.

Dosage and Administration (34068-7)

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.

Warnings and Precautions (34071-1)

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.



Section 42229-5 (42229-5)

Other Information

  • protect from freezing
  • avoid excessive heat

Section 50565-1 (50565-1)


Section 51727-6 (51727-6)

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

Section 51945-4 (51945-4)


Image of Antifungal Cream 4 oz Label

Section 53413-1 (53413-1)

Questions or comments?  1-800-962-9888

Section 55105-1 (55105-1)

Purpose

Antifungal

Section 55106-9 (55106-9)

Active Ingredient

Miconazole nitrate 2%


Advanced Ingredient Data


Raw Label Data

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