Clarus Ac Antifungal Solution

Clarus Ac Antifungal Solution
SPL v2
SPL
SPL Set ID 28ab9f1b-65cd-4405-a9a3-f3c9b836693d
Route
TOPICAL
Published
Effective Date 2021-02-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Tolnaftate (10 mg)
Inactive Ingredients
Acetylcysteine Yellow Wax Dimethyl Isosorbide Helianthus Annuus Flowering Top Lactic Acid .alpha.-tocopherol Acetate Undecylenic Acid Urea

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-03-01

Description

Tolnaftate 1%

Purpose

Topical Antifungal


Medication Information

Purpose

Topical Antifungal

Description

Tolnaftate 1%

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.
Questions?

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

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.
Active Ingredient

Tolnaftate 1%

Package Labeling:

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.

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.


Structured Label Content

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.
Purpose

Topical Antifungal

Warnings:

For external use only.

Do Not Use (Do not use)
  • on children under 2 years of age unless directed by a doctor.
Questions?

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

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.
Active Ingredient (Active ingredient)

Tolnaftate 1%

Package Labeling:

Other Information: (Other information:)
  • Protect the product in this container from excessive heat and direct sun.
Inactive Ingredients: (Inactive ingredients:)

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

When Using This Product (When using this product)
  • Avoid contact with the eyes.
Stop Use and Ask A Doctor If (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. (Keep out of reach of children.)

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


Advanced Ingredient Data


Raw Label Data

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