FUNGICURE ATHLETES FOOT (TOLNAFTATE) CREAM [DENISON PHARMACEUTICALS, LLC]

FUNGICURE ATHLETES FOOT (TOLNAFTATE) CREAM [DENISON PHARMACEUTICALS, LLC]
PDF | XML

NDC 0295-1390-32
Set ID 7f9b4ea5-e507-2346-e053-2991aa0a0b8b
Category HUMAN OTC DRUG LABEL
Packager Denison Pharmaceuticals, LLC
Generic Name
Product Class
Product Number
Application Number PART333C
  • ACTIVE INGREDIENT

    Active ingredient

    Tolnaftate 1% w/v.

  • 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:

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

    For relief of:

    • itching
    • scaling
    • cracking
    • burning
    • redness
    • soreness
    • irritation
    • discomforts which may accompany these conditions. Clears up most athlete's foot infections and with daily use helps them from coming back.

  • 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

    Butylated hydroxytoluene, menthol, PEG-75, PEG-400, titanium dioxide, white petrolatum

  • DOSAGE & ADMINISTRATION

    Directions

    • Read and all package directions and warnings before use.
    • 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 scalp or nails.
    • 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.
    • For athlete's foot and ringworm, use daily for 4 weeks. If condition persists longer, consult a doctor.
    • 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

    • 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 ATHLETES FOOT 
    tolnaftate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0295-1390
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE10 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    MENTHOL (UNII: L7T10EIP3A)  
    POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0295-1390-321 in 1 CARTON12/12/2018
    112 g in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product
    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(0295-1390)

Related Drugs