CLARUS ANTIFUNGAL- tolnaftate cream

CLARUS Antifungal by

Drug Labeling and Warnings

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

Drug Details [pdf]

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 the 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 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.

Package Labeling:

INGREDIENTS AND APPEARANCE

CLARUS ANTIFUNGAL 
tolnaftate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 44577-470
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
WATER (UNII: 059QF0KO0R)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
SUNFLOWER OIL (UNII: 3W1JG795YI)
LAURETH-7 (UNII: Z95S6G8201)
TEA TREE OIL (UNII: VIF565UC2G)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
UREA (UNII: 8W8T17847W)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 44577-470-00	1 in 1 BOX	03/11/2024
1		85 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M	03/11/2024

Labeler - Clinical Therapeutic Solutions (078402750)