Label: SOOTHE AND COOL TREAT- miconazole nitrate cream

  • NDC Code(s): 53329-080-57, 53329-080-58
  • Packager: Medline Industries, 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 January 19, 2021

If you are a consumer or patient please visit this version.

  • Active ingredient

    Miconazole Nitrate 2%

  • Purpose

    Antifungal

  • Uses

    • For the treatment of most athlete’s foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis)
    • For the treatment of superficial skin infections caused by yeast (candida albicans)
    • Relieves most itching, scaling, cracking, burning, redness, soreness, irritation, discomfort and chafing associated with jock itch
  • 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 the eyes

    Stop use and ask a doctor

    ■ if irritation occurs ■ there is no improvement within 4 weeks for athlete’s foot and ringworm ■ there is no improvement within 2 weeks for jock itch

    Keep out of reach of children.

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

  • Directions

    ■ Clean the affected area and dry thoroughly ■ Apply a thin layer over affected area twice daily or as directed by a physician ■ Supervise use by children ■ 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 scalp or nails

  • Other information

    • Protect from freezing. Avoid excessive heat.
  • Inactive ingredients

    allantoin, bees wax, cetyl dimethicone, cetyl PEG/PGG-10/1 dimethicone, fragrance, hydrogenated castor oil, imidazolidinyl urea, isopropyl palmitate, petrolatum, polymethoxy bicyclic oxazolidine, sodium chloride, water, zinc oxide.

  • Manufacturing Information

    www.medline.com

    Manufactured in USA for Medline Industries, Inc.,

    Three Lakes Drive, Northfield, IL 60093 USA.
    1-800-MEDLINE RA21SAP

  • Principal Display Panel - 5 fl oz

    Package Label

  • INGREDIENTS AND APPEARANCE
    SOOTHE AND COOL TREAT 
    miconazole nitrate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53329-080
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE20 mg  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB)  
    5-HYDROXYMETHYL(METHYLENEOXY)-1-AZA-3,7-DIOXABICYCLO(3,3,0)OCTANE (UNII: 82EKS47IC5)  
    ALLANTOIN (UNII: 344S277G0Z)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    WATER (UNII: 059QF0KO0R)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
    IMIDUREA (UNII: M629807ATL)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53329-080-57141 g in 1 TUBE; Type 0: Not a Combination Product01/01/2007
    2NDC:53329-080-5856 g in 1 TUBE; Type 0: Not a Combination Product01/01/2007
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C01/01/2007
    Labeler - Medline Industries, Inc. (025460908)
    Establishment
    NameAddressID/FEIBusiness Operations
    Swiss-American CDMO, LLC080170933manufacture(53329-080)