Label: KENDALL ANTIFUNGAL- miconazole nitrate cream
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Contains inactivated NDC Code(s)
NDC Code(s): 28851-692-01 - Packager: Covidien Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated April 14, 2011
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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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 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.
- do not get into eyes
- KEEP OUT OF REACH OF CHILDREN
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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
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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
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INGREDIENTS AND APPEARANCE
KENDALL ANTIFUNGAL
miconazole nitrate creamProduct 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)
