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 June 12, 2019

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • 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 health care 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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  • Principal Display Panel – Tube Label

    LOT   EXP

    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

    REF
    3389

    Latex–Free

    Net Weight 2 oz. • 56 g

    Made in U.S.A with globally sourced materials for

    3M Health Care
    2510 Conway Ave.
    St. Paul, MN 55144-10001-800-228-3957  3M.com/Cavilon

    3M and Cavilon are trademarks of 3M.
    © 2013, 3M. All rights reserved.

    34-8712-8872-5

    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 11/30/2010
    1 56 g in 1 TUBE; Type 0: Not a Combination Product
    2 NDC:17518-857-05 12 in 1 CASE 11/30/2010
    2 141 g in 1 TUBE; Type 0: Not a Combination Product
    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)
    Establishment
    Name Address ID/FEI Business Operations
    Swiss-American CDMO, LLC 080170933 manufacture(17518-857)
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