CONAZOL (MICONAZOLE NITRATE) CREAM [LABORATORIOS LIOMONT, S.A. DE C.V.]

CONAZOL (MICONAZOLE NITRATE) CREAM [LABORATORIOS LIOMONT, S.A. DE C.V.]
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NDC 59208-001-30
Set ID 84780538-8618-5750-e053-2a91aa0a6054
Category HUMAN OTC DRUG LABEL
Packager Laboratorios Liomont, S.A. de C.V.
Generic Name
Product Class Azole Antifungal
Product Number
Application Number PART333C
  • Active Ingredient

    Miconazole nitrate 2%

  • Purpose

    Antifungal

  • Uses

    • effective in the treatment of most athlete's foot, jock itch and ringworm
    • relieves itching, cracking, burning and discomfort associated with these conditions
  • Warnings

    For external use only

  • Do not use

    on children less than 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 of athlete's foot or ringworm within 4 weeks or jock itch within 2 weeks
  • Keep out of reach of children

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

  • Directions

    • wash 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 the spaces between the toes; wear well-fitting, ventilated shoes,and change shoes

    and socks at least once daily

    • for the athlete's foot and ringworm, use daily for 4 weeks
    • for jock itch, use daily for 2 weeks
    • not effective on the scalp or nails
  • Other Information

    • store at 20° to 25°C (68° to 77°F)
  • Inactive Ingredients

    butylated hydroxyanisole, caprylic/capic triglyceride,carbomer 980, emulsifying wax, glycerin, methylparaben, propylene glycol, propylparaben, purified water, triethanolamine

  • Package Label

    Package Label

  • INGREDIENTS AND APPEARANCE
    CONAZOL 
    miconazole nitrate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59208-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE20 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59208-001-3030 g in 1 TUBE; Type 0: Not a Combination Product03/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C03/01/2019
    Labeler - Laboratorios Liomont, S.A. de C.V. (810347807)
    Establishment
    NameAddressID/FEIBusiness Operations
    Laboratorios Liomont, S.A. de C.V.810347807manufacture(59208-001)

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