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ProClearz

Profoot, Inc.

ProClearz Anti-Fungal Pen Maximum Strength - Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient

Tolnaftate 1%

Purpose

Anti-fungal

ProClearz Uses

  • cures most athlete's foot (tinea pedis) and ringworm (tinea corporis)
  • helps prevent most athlethe's foot from recurring when used daily
  • relieves itching, scaling, cracking burning,and redness

Warnings

For external use only

  • do not use on children under 2 years of age unless directed by a doctor

When using this product

  • avoid contact with the eyes
  • if contact occurs rinse thoroughly with water

Stop use and ask doctor if

  • if irritation occurs or if there is no improvement within 4 weeks

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • wash the affected area and dry thoroughly
  • twist the end of the pen before first use by twisting the end of the pen until lotion dispenses. First time use may require 10-15 twists to prime pen
  • apply a thin layer of the product over affected area twice daily or as directed by a doctor
  • apply to skin (cuticle) surrounding the nail bed only end under nail edges where reachable with applicator brush
  • supervise children in the use of this product
  • for athlete's foot; pay special attention to spaces between toes; wear well-fitting ventilated shoes and change shoes and socks at least once daily
  • use daily for 4 weeks. If condition persists longer, consult a doctor
  • this product is not effective on the scalp or nails
  • if brush tip becomes hardened between uses, rinse with tepid water and dry thoroughly before using

Inactive Ingredients

Aloe Vera (Aloe Barbadensis) Gel, Ascorbic Acid (Vitamin C), Cetosteryl Alcohol, Dimethicone, DMDM Hydantoin, Glycerin, Glyceryl Stearate SE, Methylparaben, Mineral Oil, Polyoxyl 20 Cetostearyl Ether, Propylene Glycol, Propylparaben, Retinyl Palmitate (Vitamin A), Titanium Dioxide, Tocopheryl Acetate (Vitamin E), Water

Questions or comments?

cservice@profootcare.com or 1.800.526.FOOT (3668)

Image of Label and Carton

ProClearzPenImprintREV0712v2ESG.jpgProClearz ProClearzPenCartonFinal1013.jpgProClearz

ProClearz

Tolnaftate LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:29784-189
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Tolnaftate TOLNAFTATE 10 mg

Inactive Ingredients

Ingredient Name Strength
Aloe Vera Leaf
ASCORBIC ACID
CETOSTEARYL ALCOHOL
DIMETHICONE
DMDM HYDANTOIN
GLYCERIN
GLYCERYL STEARATE SE
METHYLPARABEN
Mineral Oil
POLYOXYL 20 CETOSTEARYL ETHER
propylene glycol
PROPYLPARABEN
VITAMIN A PALMITATE
titanium dioxide
.ALPHA.-TOCOPHEROL ACETATE
water

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:29784-189-01 3.25 in 1 APPLICATOR
2 NDC:29784-189-02 1 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
partC part333C 2012-10-23


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