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  5. Label Information: Clarus Antifungal

FDA Label for Clarus Antifungal

View Indications, Usage & Precautions

Table of Contents

    1. DRUG FACTS
    2. ACTIVE INGREDIENT
    3. PURPOSE
    4. USES:
    5. WARNINGS
    6. DO NOT USE
    7. STOP USE AND ASK PHYSICIAN IF:
    8. IF PREGNANT OR BREAST-FEEDING,
    9. KEEP OUT OF REACH OF CHILDREN
    10. DIRECTIONS:
    11. OTHER INFORMATION:
    12. INACTIVE INGREDIENTS:
    13. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
    14. PRODUCT LABEL

Clarus Antifungal Product Label

The following document was submitted to the FDA by the labeler of this product Clinical Therapeutic Solutions. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Drug Facts





Active Ingredient



Tolnaftate   1 %


Purpose



Anti-fungal


Uses:



For effective treatment of most athlete's foot (tinea pedis) and ringworm (tinea corporis).  Relieves: Itching, Scaling, Cracking, Redness, Soreness, Burning, Irritation and prevents the reoccurrence of most athlete's foot with daily use.


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:

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

    • To prevent athlete's foot:

    • 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.

Other Information:



Store between 20 0-25 0C (68 0-77 0F)


Inactive Ingredients:



Aqua (Deionized Water), C12-15 Alkyl Benzoate, C13-14 Isoparafin, Dimethyl Sulfone (MSM), Ethylhexylglycerin, Helianthus Annuus (Sunflower) Seed Oil, Laureth-7, Melaleuca Alternifolia (Tea Tree) Oil, Phenoxyethanol, Polyacrylamide, Polysorbate-20, Urea.


Package Label.Principal Display Panel



CLARUS ANTIFUNGAL CREAM   Tolnaftate 1%  MEDICAL STRENGTH ANTIFUNGAL CREAM IN A VEHICLE CONTAINING TEA TREE OIL AND UREA   CLINICAL THERAPEUTIC SOLUTIONS  NET WT.  1.5 oz (45g)  PRFOESSIONAL   Distributed by Clinical Therapeutic Solutions, PO Box 1257, Wall, NJ 07719  www.CTSRX.com


Product Label



Clarus Cream - ClarusCream

Clarus Cream - ClarusCream


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