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ProClearz

Profoot, Inc.

ProClearz Anti-Fungal Brush-On 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 athlete'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

Extremely flammable

  • keep away from fire or flame
  • avoid contact with the eyes
  • if contact occurs rinse thoroughly with water

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

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

Directions

■ shake well before using ■ wash affected area and dry thoroughly ■ apply a thin layer of the
product over affected area (around the nails and underneath nail tips) twice daily or as directed
by a doctor ■ 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 doctor ■ this product is not effective on the scalp or nails

Other Information

  • store at room temperature 15 - 30 degrees C (59 - 86 degrees F)

Inactive ingredients

Acetone, Aloe Vera (Aloe Barbadensis) Gel, Alpha Tocopherol Acetate (Vitamin E), Propylene Glycol, Water

Image of Label and Carton

ProClearzLabelFDA0712copyESG.jpgProClearz ProClearz5panelFDA0712v7ESG.jpgProClearz ProClearzVerticalFDA06122v5ESG.jpgProClearz

ProClearz

Tolnaftate LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:29784-181
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
acetone
Aloe Vera Leaf
.ALPHA.-TOCOPHEROL ACETATE
propylene glycol
water

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:29784-181-01 30 in 1 BOTTLE, WITH APPLICATOR
2 NDC:29784-181-01 30 in 1 BOTTLE, WITH APPLICATOR
3 NDC:29784-181-03 1 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
partC part333C 2012-10-22


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Be sure to consult your doctor before taking any medication!
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