Label: PROCLEARZ MAXIMUM STRENGTH ANTI-FUNGAL PEN- tolnaftate liquid 

  • NDC Code(s): 29784-189-01, 29784-189-02
  • Packager: Profoot, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 11/13

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

  • Active ingredient

    Tolnaftate 1%

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  • Purpose

    Anti-fungal

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  • Uses

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

    For external use only

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

    When using this product

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

    Stop use and ask doctor if

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

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

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  • Directions

    • wash the affected area and dry thoroughly
    • twist the end of the pen before first use by twisting the end of the pen until lotion dispenses. First time use may require 10-15 twists to prime pen
    • apply a thin layer of the product over affected area twice daily or as directed by a doctor
    • apply to skin (cuticle) surrounding the nail bed only end under nail edges where reachable with applicator brush
    • supervise children in the use of this product
    • 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
    • use daily for 4 weeks. If condition persists longer, consult a doctor
    • this product is not effective on the scalp or nails
    • if brush tip becomes hardened between uses, rinse with tepid water and dry thoroughly before using
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  • Inactive Ingredients

    Aloe Vera (Aloe Barbadensis) Gel, Ascorbic Acid (Vitamin C), Cetosteryl Alcohol, Dimethicone, DMDM Hydantoin, Glycerin, Glyceryl Stearate SE, Methylparaben, Mineral Oil, Polyoxyl 20 Cetostearyl Ether, Propylene Glycol, Propylparaben, Retinyl Palmitate (Vitamin A), Titanium Dioxide, Tocopheryl Acetate (Vitamin E), Water

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  • Questions or comments?

    cservice@profootcare.com or 1.800.526.FOOT (3668)

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  • Image of Label and Carton

    ProClearzPenImprintREV0712v2ESG.jpgLabel ProClearzPenCartonFinal1013.jpgCarton

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  • INGREDIENTS AND APPEARANCE
    PROCLEARZ  MAXIMUM STRENGTH ANTI-FUNGAL PEN
    tolnaftate liquid
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:29784-189
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    TOLNAFTATE (TOLNAFTATE) TOLNAFTATE 10 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    ALOE VERA LEAF  
    ASCORBIC ACID  
    CETOSTEARYL ALCOHOL  
    DIMETHICONE  
    DMDM HYDANTOIN  
    GLYCERIN  
    GLYCERYL STEARATE SE  
    METHYLPARABEN  
    MINERAL OIL  
    POLYOXYL 20 CETOSTEARYL ETHER  
    PROPYLENE GLYCOL  
    PROPYLPARABEN  
    VITAMIN A PALMITATE  
    TITANIUM DIOXIDE  
    .ALPHA.-TOCOPHEROL ACETATE  
    WATER  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:29784-189-02 1 in 1 BOX
    1 NDC:29784-189-01 3.25 mL in 1 APPLICATOR
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333C 10/23/2012
    Labeler - Profoot, Inc. (107570900)
    Establishment
    Name Address ID/FEI Business Operations
    Dhaliwal Labs 016754201 manufacture(29784-189)
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