CLARUS AC ANTIFUNGAL SOLUTION- tolnaftate liquid

CLARUS AC Antifungal Solution by

Drug Labeling and Warnings

CLARUS AC Antifungal Solution by is a Otc medication manufactured, distributed, or labeled by Clinical Therapeutic Solutions. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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?

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Package Labeling:

INGREDIENTS AND APPEARANCE

CLARUS AC ANTIFUNGAL SOLUTION 
tolnaftate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 44577-128
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV)	TOLNAFTATE	10 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 44577-128-00	15 g in 1 TUBE; Type 0: Not a Combination Product	03/01/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M005	03/01/2021

Labeler - Clinical Therapeutic Solutions (078402750)