CLARUS Antifungal description, usages, side effects, indications, overdosage, supplying and lots more!

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CLARUS Antifungal

Clinical Therapeutic Solutions

CLARUS Antifungal


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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.

  • 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

CLARUS Antifungal

TOLNAFTATE CREAM

Product Information

Product Type Human otc drug label Item Code (Source) NDC:44577-001
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Tolnaftate TOLNAFTATE 1 g

Inactive Ingredients

Ingredient Name Strength
water
ALKYL (C12-15) BENZOATE
C13-14 ISOPARAFFIN
DIMETHYL SULFONE
ETHYLHEXYLGLYCERIN
SUNFLOWER OIL
LAURETH-7
TEA TREE OIL
PHENOXYETHANOL
POLYSORBATE 20
UREA

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:44577-001-01 45 in 1 TUBE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
partC part333C 2012-06-07


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