Label: CLARUS AC ANTIFUNGAL SOLUTION- tolnaftate liquid

  • NDC Code(s): 44577-128-00
  • Packager: Clinical Therapeutic Solutions
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 10, 2023

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  • Active ingredient

    Tolnaftate 1%

    Purpose

    Topical Antifungal

  • Uses:

    • Proven clinically effective in the treatment of most fungal infections including related/associated to tinea pedis (athlete’s foot), tinea cruris (jock itch) and tinea corporis (ringworm). 
    • For effective relief of itching, scaling, cracking, burning, redness, soreness, irritation, discomfort associated to fungal infections. 
    • Prevents most tinea pedis (athlete's foot) with daily use.
  • Warnings:

    For external use only.

    Do not use

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

    When using this product

    • Avoid contact with the eyes.

    Stop use and ask a doctor if

    If irritation occurs or if there is no improvement within 4 weeks, discontinue use and consult a doctor.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions:

    • 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 doctor. 
    • Pay special attention to spaces between the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily.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:

    • Protect the product in this container from excessive heat and direct sun.
  • Inactive ingredients:

    N-Acetylcysteine, Beeswax, Dimethyl Isosorbite, Helianthus Annuus (Sunflower) Oil, Lactic Acid, Tocopheryl Acetate (Vitamin E), Undecylenic Acid, Urea.

  • Questions?

    (M-F) (9am-5pm EST) 732-894-9450

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    CLARUS AC ANTIFUNGAL SOLUTION 
    tolnaftate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:44577-128
    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
    ACETYLCYSTEINE (UNII: WYQ7N0BPYC)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    DIMETHYL ISOSORBIDE (UNII: SA6A6V432S)  
    HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)  
    LACTIC ACID (UNII: 33X04XA5AT)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    UNDECYLENIC ACID (UNII: K3D86KJ24N)  
    UREA (UNII: 8W8T17847W)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:44577-128-0015 g in 1 TUBE; Type 0: Not a Combination Product03/01/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00503/01/2021
    Labeler - Clinical Therapeutic Solutions (078402750)