Label: GENRX DAILY DEFENSE ANTIFUNGAL- miconazole nitrate cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 01/13

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  • Active ingredient

    Miconazole Nitrate 2.0%

    Purpose

    Antifungal

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  • Uses

    ■ for the treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis)
    ■ relieves itching, scaling, cracking, burning, redness, soreness, irritation, discomfort and chafing associated with jock itch

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  • Warnings

    For external use only

    Do not use on

    children under 2 years of age unless directed by a doctor

    When using this product

    avoid contact with eyes

    Stop use and ask a doctor if

    ■ for athlete's foot and ringworm - irritation occurs or there is no improvement within 4 weeks
    ■ for jock itch - irritation occurs or there is no improvement within 2 weeks

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

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  • Directions

    ■ clean the affected area and dry thoroughly
    ■ apply a thin layer of the product over 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 4 weeks
    ■ for jock itch, use daily for 2 weeks
    ■ if condition persists longer, consult a doctor. This product is not effective on the scalp or nails.

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  • Other information

    ■ protect from freezing    ■ avoid excessive heat

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  • Inactive ingredients

    Aleurites moluccana seed oil, butylene glycol, caprylyl glycol, Carthamus tinctorius (safflower) seed oil, cetyl alcohol, cetyl phosphate, chlorphenesin, dimethicone, dimethicone crosspolymer, disodium EDTA, fragrance, glycerin, glyceryl stearate, GenRx Complex™ [consisting of: bisabolol, calcium pantothenate (vitamin B5), Carthamus tinctorius (safflower) oleosomes, maltodextrin, niacinamide (vitamin B3), pyridoxine HCl (vitamin B6), silica, sodium ascorbyl phosphate (vitamin C), sodium starch octenylsuccinate, tocopheryl acetate (vitamin E), Zingiber officinale (ginger) root extract], PEG-100 stearate, pentylene glycol, phenoxyethanol, purified water, sodium hyaluronate, sodium hydroxide, stearyl alcohol.

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  • Daily Defense Antifungal Cream with GenRx Complex​TM (4 oz tube label)
  • INGREDIENTS AND APPEARANCE
    GENRX DAILY DEFENSE ANTIFUNGAL 
    miconazole nitrate cream
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:59088-746
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MICONAZOLE NITRATE (MICONAZOLE) MICONAZOLE NITRATE 20 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    KUKUI NUT OIL  
    BUTYLENE GLYCOL  
    CAPRYLYL GLYCOL  
    SAFFLOWER OIL  
    CETYL ALCOHOL  
    CETYL PHOSPHATE  
    CHLORPHENESIN  
    DIMETHICONE/DIENE DIMETHICONE CROSSPOLYMER  
    EDETATE DISODIUM  
    GLYCERIN  
    GLYCERYL MONOSTEARATE  
    LEVOMENOL  
    CALCIUM PANTOTHENATE  
    CARTHAMUS TINCTORIUS SEED OLEOSOMES  
    MALTODEXTRIN  
    NIACINAMIDE  
    PYRIDOXINE HYDROCHLORIDE  
    SILICON DIOXIDE  
    SODIUM ASCORBYL PHOSPHATE  
    .ALPHA.-TOCOPHEROL ACETATE, DL-  
    GINGER  
    PEG-100 STEARATE  
    PENTYLENE GLYCOL  
    PHENOXYETHANOL  
    WATER  
    HYALURONATE SODIUM  
    SODIUM HYDROXIDE  
    STEARYL ALCOHOL  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:59088-746-08 118 mL in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333C 01/08/2013
    Labeler - PureTek Corporation (785961046)
    Establishment
    Name Address ID/FEI Business Operations
    PureTek Corporation 785961046 manufacture(59088-746), pack(59088-746), label(59088-746)
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