Label: SUNMARK ANTIFUNGAL- tolnaftate cream

  • NDC Code(s): 49348-155-29
  • Packager: Strategic Sourcing Services LLC
  • Category: HUMAN OTC DRUG LABEL

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 November 26, 2019

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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

  • PRINCIPAL DISPLAY PANEL - 15 g Tube Carton

    sunmark™

    antifungal cream

    Tolnaftate 1%
    CURES & PREVENTS MOST ATHLETE'S FOOT

    NET WT 0.5 OZ (15 g)

    PRINCIPAL DISPLAY PANEL - 15 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    SUNMARK   ANTIFUNGAL
    tolnaftate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)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:49348-155-291 in 1 CARTON02/13/2013
    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 FINALpart333C02/17/2006
    Labeler - Strategic Sourcing Services LLC (116956644)
    Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370)
    Establishment
    NameAddressID/FEIBusiness Operations
    Taro Pharmaceuticals Inc.206263295MANUFACTURE(49348-155)
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