FUNGICURE LIQUID GEL (CLOTRIMAZOLE) LIQUID [DENISON PHARMACEUTICALS, LLC]

FUNGICURE LIQUID GEL (CLOTRIMAZOLE) LIQUID [DENISON PHARMACEUTICALS, LLC]
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NDC 0295-1363-31
Set ID 7fa89075-5501-3441-e053-2991aa0ae0ff
Category HUMAN OTC DRUG LABEL
Packager Denison Pharmaceuticals, LLC
Generic Name
Product Class Azole Antifungal
Product Number
Application Number PART333C
  • ACTIVE INGREDIENT

    Active ingredient

    Clotrimazole 1% w/w.

  • PURPOSE

    Purpose

    Antifungal

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a poison center right away.

  • INDICATIONS & USAGE

    Uses

    For the cure of most:

    • ringworm (tinea corpis)
    • athlete's foot (tinea pedis)

    For relief of:

    • itching
    • scaling
    • cracking
    • burning
    • redness
    • soreness
    • irritation
    • discomforts which may accompany these conditions

  • WARNINGS

    Warnings

    For external use only.

    Ask a doctor before use on children under 2 years of age.

    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
  • INACTIVE INGREDIENT

    Inactive ingredient

    Hydroxypropylcellulose and Isopropyl alcohol

  • DOSAGE & ADMINISTRATION

    Directions

    • Read and all package directions and warnings before using.
    • Use only as directed.
    • Clean the affected area with soap with warm water and dry thoroughly.
    • Apply a thin layer of FUNGICURE over the affected area twice daily (morning and night), or as directed by a doctor.
    • This product is not effective on the scalp or nails.
    • Avoid applying to severly cracked or irritated areas.
    • For ringworm and athlete's foot, use daily for 4 weeks. If condition persists longer, consult a doctor.
    • For athlete's foot: pay special attention to spaces between toes; wear well fitting, ventilated shoes, and change shoes and socks at least once daily.
    • Intented for use by normally healthy adults only.
    • Persons under 18 years of age or those with highly sensitive or allergic skin should use only as directed by a doctor.
    • Supervise children in the use of this product.
  • OTHER SAFETY INFORMATION

    Other information

    • FUNGICURE may be applied to exposed nail-beds, cuticles, around nail edges and under nail tips where reachable with its applicator brush
    • This product is not intended to, nor will it, penetrate hard nail surfaces.
    • While not all finger and toe fungal infections are curable with OTC topical medications, if you see improvement within 4 weeks of use, you may continue to use FUNGICURE until satisfactory results are obtained.
    • You may report serious side effects to the phone number provided under Questions? below
  • QUESTIONS

    Questions? 1-800-792-2582

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    FUNGICURE LIQUID GEL 
    clotrimazole liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0295-1363
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    HYDROXYPROPYL CELLULOSE (TYPE M) (UNII: U3JF91U133)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0295-1363-3110.5 mL in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product12/12/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C12/12/2018
    Labeler - Denison Pharmaceuticals, LLC (001207208)
    Establishment
    NameAddressID/FEIBusiness Operations
    Denison Pharmaceuticals, LLC001207208manufacture(0295-1363)

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