Label: 3M CAVILON ANTIFUNGAL- miconazole nitrate cream

  • NDC Code(s): 17518-857-02, 17518-857-05
  • Packager: 3M Health Care
  • 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 November 11, 2010

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  • Drug Facts
  • Active ingredient

    Miconazole Nitrate 2%

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  • Purpose

    Antifungal

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  • Indications

    • Proven clinically effective in the treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris) and ringworm (tinea corporis)
    • For the treatment of superficial skin infections caused by yeast (candida albicans)
    • For effective relief of redness, irritation, scaling, itching, discomfort and burning
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  • Warnings

    • For external use only
    • Not intended for ingestion
    • Do not use on children under 2 years of age unless directed by a doctor
    • Avoid contact with the eyes

    • For the treatment of athlete's foot and ringworm: If irritation occurs or if there is no improvement within 4 weeks, discontinue use and consult a doctor
    • For the treatment of jock itch: If irritation occurs or there is no improvement within 2 weeks, discontinue use and consult a doctor
    • For the prevention of athlete's foot: If irritation occurs, discontinue use and consult a doctor
    • Do not use for diaper rash

    • Keep out of the reach of children
    • If swallow, 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. As directed by a doctor or healthcare professional
    • 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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  • Inactive ingredients

    • Allantoin, Beeswax, Cetyl Dimethicone, Cetyl PEG/PPG-10/1 Dimethicone, Dimethicone, Disodium EDTA, Fragrance, Hydrogenated Castor Oil, Isopropyl Palmitate, Methylparaben, Petrolatum, Propylene Glycol, Propylparaben, Purified Water, Sodium Chloride, Zinc Oxide
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  • Questions? 1-800-228-3957
  • Principal Display Panel – Tube Label

    3M        NDC 17518-857-02

    Cavilon™

    Antifungal Cream

    Miconazole Nitrate 2%

    • For effective relief of redness, irritation, scaling, itching, discomfort and burning
    • Enriched with water-repelling ingredients

    3389

    Latex –Free

    Net Weight 2 oz. • 56 g

    Made in U.S.A for

    3M Health Care

    St. Paul, MN 55144-1000

    1-800-228-3957

    www.3M.com/Cavilon

    © 2010, 3M. All rights reserved.

    3M and Cavilon are trademarks of 3M.

    34-8706-0175-3

    Principal Display Panel – Tube Label
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  • INGREDIENTS AND APPEARANCE
    3M CAVILON ANTIFUNGAL 
    miconazole nitrate cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:17518-857
    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 1000 g
    Inactive Ingredients
    Ingredient Name Strength
    water (UNII: 059QF0KO0R)  
    allantoin (UNII: 344S277G0Z)  
    edetate disodium (UNII: 7FLD91C86K)  
    sodium chloride (UNII: 451W47IQ8X)  
    methylparaben (UNII: A2I8C7HI9T)  
    propylene glycol (UNII: 6DC9Q167V3)  
    petrolatum (UNII: 4T6H12BN9U)  
    dimethicone (UNII: 92RU3N3Y1O)  
    Propylparaben (UNII: Z8IX2SC1OH)  
    white wax (UNII: 7G1J5DA97F)  
    Hydrogenated castor oil (UNII: ZF94AP8MEY)  
    zinc oxide (UNII: SOI2LOH54Z)  
    Isopropyl palmitate (UNII: 8CRQ2TH63M)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:17518-857-02 24 in 1 CASE
    1 56 g in 1 TUBE
    2 NDC:17518-857-05 12 in 1 CASE
    2 141 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333C 11/30/2010
    Labeler - 3M Health Care (006173082)
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