Clarus Antifungal

Clarus Antifungal
SPL v6
SPL
SPL Set ID 7e8897ff-67d1-4336-866e-cb76a36edddc
Route
TOPICAL
Published
Effective Date 2012-06-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Tolnaftate (1 g)
Inactive Ingredients
Water Alkyl (c12-15) Benzoate C13-14 Isoparaffin Dimethyl Sulfone Ethylhexylglycerin Sunflower Oil Laureth-7 Tea Tree Oil Phenoxyethanol Polysorbate 20 Urea

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2012-06-07

Description

Tolnaftate   1 %

Purpose

Anti-fungal


Medication Information

Purpose

Anti-fungal

Description

Tolnaftate   1 %

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.

Section 51945-4

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

Warnings

For external use only.  Avoid contact with eyes.

Do Not Use

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

Drug Facts



Directions:

For treatment of athlete's foot and ringworm:

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

Active Ingredient

Tolnaftate   1 %

Other Information:

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

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.

Keep Out of Reach of Children

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

If Pregnant Or Breast Feeding,

ask a healthcare professional before use.

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.


Structured Label Content

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.

Section 51945-4 (51945-4)

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

Purpose

Anti-fungal

Warnings

For external use only.  Avoid contact with eyes.

Do Not Use (Do not use)

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

Drug Facts



Directions:

For treatment of athlete's foot and ringworm:

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

Active Ingredient

Tolnaftate   1 %

Other Information: (Other information:)

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

Inactive Ingredients: (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.

Keep Out of Reach of Children (Keep out of reach of children)

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

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a healthcare professional before use.

Stop Use and Ask Physician If: (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.


Advanced Ingredient Data


Raw Label Data

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