Label: FUNGICURE LIQUID GEL- clotrimazole liquid

  • NDC Code(s): 0295-1363-31
  • Packager: Denison Pharmaceuticals, LLC
  • 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 17, 2019

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

  • 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)