Your browser does not support JavaScript! PROCLEARZ MAXIMUM STRENGTH ANTI-FUNGAL PEN (TOLNAFTATE) LIQUID [PROFOOT, INC.]
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PROCLEARZ MAXIMUM STRENGTH ANTI-FUNGAL PEN (tolnaftate) liquid
[Profoot, Inc.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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.
Drug Label Sections

Active ingredient

Tolnaftate 1%

Purpose

Anti-fungal

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.jpgLabel ProClearzPenCartonFinal1013.jpgCarton

PROCLEARZ  MAXIMUM STRENGTH ANTI-FUNGAL PEN
tolnaftate liquid
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:29784-189
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TOLNAFTATE (TOLNAFTATE) TOLNAFTATE10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:29784-189-021 in 1 BOX
1NDC:29784-189-013.25 mL in 1 APPLICATOR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C10/23/2012
Labeler - Profoot, Inc. (107570900)
Establishment
NameAddressID/FEIBusiness Operations
Dhaliwal Labs016754201manufacture(29784-189)

Revised: 11/2013
 
Profoot, Inc.

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