Label: CLARUS ANTIFUNGAL- tolnaftate solution

  • NDC Code(s): 44577-002-01
  • Packager: Clinical Therapeutic Solutions
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 5, 2023

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

  • Drug Facts


  • Active Ingredient

    Tolnaftate   1 %

  • Purpose

    Anti-fungal

  • Uses:

    For effective treatment of most athlete's foot and ringworm. Relieves:

    Prevents the reoccurrence of most athlete's foot with daily use.

    • Itching
    • Scaling
    • Cracking
    • Redness
    • Soreness
    • Burning
    • Irritation
  • Warnings

    For external use only.  Avoid contact with eyes.

    Do not use

    on children under 2 years of age unless directed by a physician.

    Stop use and ask physician if:

    • When using for athlete's foot or ringworm:  if irritation occurs or if there is no improvement within 4 weeks, discontinue use and consult a physician.
    • When using for prevention of athlete's foot: If irritation occurs, discontinue use and consult a physician.

    If pregnant or breast-feeding,

    ask a healthcare professional before use.

    Keep out of reach of children

    In the case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

  • Directions:

    For treatment of athlete's foot and ringworm:

    If condition persists longer, consult a physician. This product is not effective on scalp or nail infections.

    To prevent athlete's foot:

    • Clean the affected area and dry thoroughly. Apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a physician.
    • 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.
    • Clean the feet and dry thoroughly.
    • Apply a thin layer of the product to the feet once or twice daily (morning and/or night).
    • Supervise children in the use of this product.
    • Pay special attention to spaces between the toes; wear well-fitting shoes, and change shoes and socks at least once daily.
  • Questions or Comments?

    Please visit  www.CTSRX.com

  • Inactive ingredients:

    Amygdalus Dulcis (Sweet Almond) Oil, BHT, Helianthus Annuus (Sunflower) Seed Oil, Mentha Piperita (Peppermint) Oil, Sesamum Indicum (Sesame) Seed Oil, Tocopheryl Acetate (Vitamin E).

  • PRINCIPAL DISPLAY PANEL

    CLARUS ANTIFUNGAL SOLUTION Tolnaftate 1%  MEDICAL STRENGTH ANTIFUNGAL SOLUTION CLINICAL THERAPEUTIC SOLUTIONS  PO Box 1257, Wall, NJ 07719   0.5 FL OZ (15 mL)

  • Product Label

    Clarus Solution

  • INGREDIENTS AND APPEARANCE
    CLARUS ANTIFUNGAL 
    tolnaftate solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:44577-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALMOND OIL (UNII: 66YXD4DKO9)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    SESAME OIL (UNII: QX10HYY4QV)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:44577-002-0115 mL in 1 BOTTLE; Type 0: Not a Combination Product02/06/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00506/07/2012
    Labeler - Clinical Therapeutic Solutions (078402750)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pure Source, LLC080354456manufacture(44577-002)