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CLARUS Antifungal by Clinical Therapeutic Solutions

Dosage form: cream
Ingredients: TOLNAFTATE 1g in 100g
Labeler: Clinical Therapeutic Solutions
NDC Code: 44577-001

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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:

  • 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 200-250C (680-770F)

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 ANTIFUNGAL 
tolnaftate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:44577-001
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TOLNAFTATE (TOLNAFTATE) TOLNAFTATE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER 
ALKYL (C12-15) BENZOATE 
C13-14 ISOPARAFFIN 
DIMETHYL SULFONE 
ETHYLHEXYLGLYCERIN 
SUNFLOWER OIL 
LAURETH-7 
TEA TREE OIL  
PHENOXYETHANOL 
POLYSORBATE 20 
UREA 
Packaging
#Item CodePackage Description
1NDC:44577-001-0145 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C06/07/2012
Labeler - Clinical Therapeutic Solutions (078402750)
Establishment
NameAddressID/FEIOperations
Pure Source Inc.969241041manufacture

Revised: 06/2012
 
Clinical Therapeutic Solutions

← See all CLARUS Antifungal brands

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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