Label: SUNMARK ANTIFUNGAL- tolnaftate cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 16, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Tolnaftate 1%

  • Purpose

    Antifungal

  • Uses

    • clinically proven to cure most athlete's foot (tinea pedis), jock itch (tinea cruris) and ringworm (tinea corporis)
    • helps prevent most athlete's foot from recurring when used daily
    • effectively soothes and relieves symptoms of athlete's foot, including itching, burning and cracking
  • Warnings

    For external use only

    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 or ringworm) or within 2 weeks (for jock itch)

    Do not use on children under 2 years of age except under the advice and supervision of a doctor.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • wash affected area and dry thoroughly
    • apply a thin layer over affected area twice daily (morning and night)
    • supervise children in the use of this product
    • this product is not effective on scalp or nails

    For athlete's foot

    • pay special attention to spaces between toes
    • wear well-fitting shoes, change shoes and socks at least once daily

    For athlete's foot and ringworm use daily for 4 weeks

    For jock itch use daily for 2 weeks
    If condition persists longer, consult a doctor

  • Other information

    • Store between 15° - 30°C (59° - 86°F)
    • See end panel of carton and tube crimp for lot number and expiration date
  • Inactive ingredients

    BHT, PEG-400, PEG-3350, titanium dioxide, white petrolatum

  • SPL UNCLASSIFIED SECTION

    Distributed by McKesson
    One Post Street
    San Francisco, CA 94104

  • HOW SUPPLIED

    Product: 50090-3358

    NDC: 50090-3358-0 15 g in a TUBE / 1 in a CARTON

  • Tolnaftate

    Label Image
  • INGREDIENTS AND APPEARANCE
    SUNMARK   ANTIFUNGAL
    tolnaftate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50090-3358(NDC:49348-155)
    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
    Butylated Hydroxytoluene (UNII: 1P9D0Z171K)  
    Polyethylene Glycol 400 (UNII: B697894SGQ)  
    Polyethylene Glycol 3350 (UNII: G2M7P15E5P)  
    titanium dioxide (UNII: 15FIX9V2JP)  
    petrolatum (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50090-3358-01 in 1 CARTON02/01/2018
    115 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00502/17/2006
    Labeler - A-S Medication Solutions (830016429)
    Establishment
    NameAddressID/FEIBusiness Operations
    A-S Medication Solutions830016429RELABEL(50090-3358)
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