KENDALL ANTIFUNGAL  - miconazole nitrate cream 
Covidien Inc.

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.

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Kendall Antifungal Cream

Active Ingredient

Miconazole nitrate 2%

Purpose

Antifungal

Uses

Warnings

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

For external use only.

When using this product 
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

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

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 AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (Miconazole - UNII:7NNO0D7S5M) MICONAZOLE NITRATE2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
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: 4/2011
Document Id: c12520f1-5f04-406a-b40e-7234ff61ee61
Set id: 2a6a95af-3c22-44e7-a08a-c8cdfda98a21
Version: 1
Effective Time: 20110414
 
Covidien Inc.