Label: PROCLEARZ MAXIMUM STRENGTH FUNGAL SHIELD BRUSH-ON ANTIFUNGAL- tolnaftate solution

  • NDC Code(s): 29784-181-01, 29784-181-02
  • Packager: Profoot, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 22, 2023

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  • Active Ingredient

    Tolnaftate 1%

  • Purpose

    Anti-fungal

  • Uses

    • cures most athlete's foot (tinea pedis) and ringworm (tinea corporis)
    • helps prevent most athlete's foot from recurring when used daily
    • relieves itching, scaling, cracking, burning, and redness
  • Warnings

    For external use only

    • do not use on children under 2 years of age unless directed by a doctor
  • GENERAL PRECAUTIONS

    Extremely flammable

    • keep away from fire or flame
  • When using this product

    • avoid contact with the eyes
    • if contact occurs rinse thoroughly with water

  • Stop use and ask a doctor if

    • irritation occurs or if there is no improvement in 4 weeks
  • KEEP OUT OF REACH OF CHILDREN

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

  • Directions

    ■ shake well before using ■ wash affected area and dry thoroughly ■ apply a thin layer of the product over affected area (around the nails and underneath nail tips) twice daily or as directed by a doctor ■ supervise children in the use of this product ■ for athlete’s foot, pay special attention to spaces between the 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 ■ this product is not effective on the scalp or nails




  • Other Information

    • store at room temperature 15º-30ºC (59º-86ºF)
  • Inactive ingredients

    Acetone, Aloe Vera (Aloe Barbadensis) Gel, Propylene Glycol, Tocopherol Acetate (Vitamin E), Water

  • PRINCIPAL DISPLAY PANEL

    updated outer boxDrug Facts PanelUpated Inner Label

  • INGREDIENTS AND APPEARANCE
    PROCLEARZ  MAXIMUM STRENGTH FUNGAL SHIELD BRUSH-ON ANTIFUNGAL
    tolnaftate solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:29784-181
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ACETONE (UNII: 1364PS73AF)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:29784-181-021 in 1 BOX10/22/2012
    1NDC:29784-181-0130 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00510/22/2012
    Labeler - Profoot, Inc. (107570900)