KENDALL ANTIFUNGAL (MICONAZOLE NITRATE) CREAM [COVIDIEN INC.]

KENDALL ANTIFUNGAL (MICONAZOLE NITRATE) CREAM [COVIDIEN INC.]
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NDC 28851-692-01
Set ID 2a6a95af-3c22-44e7-a08a-c8cdfda98a21
Category HUMAN OTC DRUG LABEL
Packager Covidien Inc.
Generic Name
Product Class Azole Antifungal
Product Number
Application Number PART333C
  • 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

    Image of Antifungal Cream 4 oz Label

  • INGREDIENTS AND APPEARANCE
    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)

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