CLARUS ANTIFUNGAL- tolnaftate cream 
Clinical Therapeutic Solutions

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CLARUS Antifungal

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 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:

To prevent athlete's foot:

Other information:

Store between 20 -25 C (68 -77 F) 0000

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.

CLARUS ANTIFUNGAL CREAM   Tolnaftate 1%  MEDICAL STRENGTH ANTIFUNGAL CREAM IN A VEHICLE CONTAINING TEA TREE OIL AND UREA   CLINICAL THERAPEUTIC SOLUTIONS  NET WT.  1.5 oz (45g)  PRFOESSIONAL   Distributed by Clinical Therapeutic Solutions, PO Box 1257, Wall, NJ 07719  www.CTSRX.com

Product Label

Clarus Cream

CLARUS ANTIFUNGAL 
tolnaftate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:44577-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE1 g  in 100 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:44577-001-0145 g in 1 TUBE; Type 0: Not a Combination Product02/05/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00506/07/2012
Labeler - Clinical Therapeutic Solutions (078402750)
Establishment
NameAddressID/FEIBusiness Operations
Pure Source, LLC080354456manufacture(44577-001)

Revised: 11/2023
Document Id: 0973b73d-5dc0-0986-e063-6294a90a5917
Set id: 7e8897ff-67d1-4336-866e-cb76a36edddc
Version: 6
Effective Time: 20231105
 
Clinical Therapeutic Solutions