Kendall Antifungal

Dosage form: cream
Ingredients: MICONAZOLE NITRATE 2g in 100g
Labeler: Covidien Inc.
NDC Code: 28851-692

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Kendall Antifungal Cream

Active Ingredient

Miconazole nitrate 2%

Purpose

Antifungal

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

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.



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 Information

  • protect from freezing
  • avoid excessive heat

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 or comments?  1-800-962-9888


Image of Antifungal Cream 4 oz Label

KENDALL ANTIFUNGAL  
miconazole nitrate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:28851-692
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MICONAZOLE NITRATE (Miconazole) MICONAZOLE NITRATE2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 
Packaging
#Item CodePackage Description
1NDC:28851-692-01118 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C04/14/2011
Labeler - Covidien Inc. (805770828)

Revised: 04/2011
 
Covidien Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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