KENDALL ANTIFUNGAL- miconazole nitrate cream

Kendall Antifungal by

Drug Labeling and Warnings

Kendall Antifungal by is a Otc medication manufactured, distributed, or labeled by Covidien Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient

Miconazole nitrate 2%

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.

KEEP OUT OF REACH OF CHILDREN

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.

SPL UNCLASSIFIED SECTION

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

QUESTIONS

Questions or comments?  1-800-962-9888

PRINCIPAL DISPLAY PANEL

Image of Antifungal Cream 4 oz Label

INGREDIENTS AND APPEARANCE

KENDALL ANTIFUNGAL  
miconazole nitrate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 28851-692
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (Miconazole - UNII:7NNO0D7S5M)	MICONAZOLE NITRATE	2 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
MINERAL OIL (UNII: T5L8T28FGP)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
CETYL ALCOHOL (UNII: 936JST6JCN)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
SODIUM LACTATE (UNII: TU7HW0W0QT)
JOJOBA OIL (UNII: 724GKU717M)
POLYSORBATE 60 (UNII: CAL22UVI4M)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
DIMETHICONE (UNII: 92RU3N3Y1O)
SHEA BUTTER (UNII: K49155WL9Y)
CETYL HYDROXYETHYLCELLULOSE (350000 MW) (UNII: T7SWE4S2TT)
METHYLPARABEN (UNII: A2I8C7HI9T)
1-DECENE (UNII: 7O4U4C718P)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
XANTHAN GUM (UNII: TTV12P4NEE)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 28851-692-01	118 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	04/14/2011

Labeler - Covidien Inc. (805770828)