CLARUS ANTIFUNGAL- tolnaftate cream 
Clinical Therapeutic Solutions

----------

CLARUS Antifungal Cream

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:

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:

Label

CLARUS ANTIFUNGAL 
tolnaftate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:44577-470
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:44577-470-001 in 1 BOX03/11/2024
185 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM03/11/2024
Labeler - Clinical Therapeutic Solutions (078402750)

Revised: 2/2024
Document Id: 126eb818-7e35-3cce-e063-6294a90a5e69
Set id: 835c3c23-fc3c-404e-8e87-5a0176126730
Version: 1
Effective Time: 20240228
 
Clinical Therapeutic Solutions