Clarus Antifungal Cream

Clarus Antifungal Cream
SPL v1
SPL
SPL Set ID 835c3c23-fc3c-404e-8e87-5a0176126730
Route
TOPICAL
Published
Effective Date 2024-02-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Tolnaftate (10 mg)
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 2024-03-11

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.

Warnings:

For external use only. Avoid contact with the 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:

  • 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.
Active Ingredient

Tolnaftate 1 %

Package Labeling:

Other Information:

Store between 20º -25ºC (68º -77ºF)

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.

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.

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.

Purpose

Anti-fungal

Warnings:

For external use only. Avoid contact with the 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:

  • 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.
Active Ingredient

Tolnaftate 1 %

Package Labeling:

Other Information: (Other information:)

Store between 20º -25ºC (68º -77ºF)

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.

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

ask a healthcare professional before use.

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.

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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