Label: MIRACLE PLUS ANTI-FUNGAL- tolnaftate cream 

  • NDC Code(s): 64058-615-12
  • Packager: Concept Laboratories, 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 04/13

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active ingredient

    Tolnaftate 1%

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  • Purpose

    Antifungal

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  • Uses

    for effective treatment of most athlete's foot (tinea pedis)   Relieves

    • itching
    • scaling
    • cracking
    • burning
    • 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

    • if pregnant or nursing, seek the advice of a health professional before using

    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 within 4 weeks

    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
    • apply a thin layer of the product over affected area 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 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
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  • Inactive ingredients

    Water (Aqua), Glyceryl Stearate SE, Glycerin, Ceteareth 20, Mineral Oil, Cetearyl Alcohol, Propylene Glycol, Aloe Barbadensis Leaf Juice, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Tocopheryl Acetate, Ascorbic Acid, Dimethicone, Titanium Dioxide, Retinyl Palmitate, DMDM Hydantoin, Methylparaben, Propylparaben, Fragrance.

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  • Questions or comments?

    Call 1-888-373-8831 or www.conceptlabs.org

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  • SPL UNCLASSIFIED SECTION

    Manufactured by Concept Laboratories, Inc.
    Chicago, IL 60642 (USA)

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  • PRINCIPAL DISPLAY PANEL - 59 mL Bottle Label

    MIRACLE
    PLUS®

    TOLNAFTATE 1%
    Anti-Fungal
    Foot Relief

    ATHLETE'S FOOT CREAM

    • Cures Most Athlete's Foot
      and Harmful Fungus
    • Relieves Itching, Cracking,
      Burning, Redness, Scaling
    • Beneficial Tea Tree, Aloe
      Vera and Vitamins A, C & E

    2 FL OZ (59mL)

    NDC 64058-615-12

    Principal Display Panel - 59 mL Bottle Label
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  • INGREDIENTS AND APPEARANCE
    MIRACLE PLUS ANTI-FUNGAL 
    tolnaftate cream
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:64058-615
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Tolnaftate (Tolnaftate) Tolnaftate 0.59 g  in 59 g
    Inactive Ingredients
    Ingredient Name Strength
    Water  
    Glycerin  
    GLYCERYL MONOSTEARATE  
    MINERAL OIL  
    ALOE VERA LEAF  
    TITANIUM DIOXIDE  
    DIMETHICONE  
    ASCORBIC ACID  
    TEA TREE OIL  
    VITAMIN A PALMITATE  
    DMDM HYDANTOIN  
    PROPYLENE GLYCOL  
    METHYLPARABEN  
    PROPYLPARABEN  
    POLYOXYL 20 CETOSTEARYL ETHER  
    CETOSTEARYL ALCOHOL  
    .ALPHA.-TOCOPHEROL ACETATE  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:64058-615-12 59 g in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part333C 01/04/2011
    Labeler - Concept Laboratories, Inc. (962282612)
    Establishment
    Name Address ID/FEI Business Operations
    Concept Laboratories, Inc. 962282612 MANUFACTURE(64058-615)
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