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ProClearz Fungi-Cide PM

Medically reviewed on March 5, 2018

Dosage form: cream
Ingredients: TOLNAFTATE 1g in 100g
Labeler: Profoot, Inc.
NDC Code: 29784-191

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.

ProClearz Fungi-Cide PM

Active ingredient

Tolnaftate 1%

Purpose

Anti-fungal

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

When using this product

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

Stop use and ask doctor 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 affected area and dry thoroughly ■ apply a thin layer of the product over affected area (around the nails and underneath nail tips) ■ allow to dry 5-7 minutes to form a white protective barrier ■ use nightly or as directed by a doctor up to twice daily. ■ 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

Inactive Ingredients

Acrylates Copolymer, C13-14 Isoparaffin, Ceteareth-20, Cetearyl Alcohol, Dimethicone, DMDM Hydantoin, Elettaria Cardamomum Seed Oil, Glycerin, Glyceryl Stearate SE, Laureth-7, Methylparaben, Mineral Oil, Octadecene/MA Copolymer, Polyacrylamide, Propylene Glycol, Propylparaben, Retinyl Palmitate, Sodium Hydroxide, Titanium Dioxide, Tocopheryl Acetate, Water (Aqua)

Questions or comments?

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

Image of 26g Label and Carton

PCFungiPMtube90x25copy.jpg ProClearzFungiPMCarton214finalcopy.jpg

PROCLEARZ  FUNGI-CIDE PM
tolnaftate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:29784-191
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TOLNAFTATE (TOLNAFTATE) TOLNAFTATE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
C13-14 ISOPARAFFIN 
DIMETHICONE 
DMDM HYDANTOIN 
ELETTARIA CARDAMOMUM WHOLE 
GLYCERIN 
GLYCERYL MONOSTEARATE 
LAURETH-7 
METHYLPARABEN 
MINERAL OIL 
POLYACRYLAMIDE (1500 MW) 
PROPYLENE GLYCOL 
PROPYLPARABEN 
VITAMIN A PALMITATE 
SODIUM HYDROXIDE 
TITANIUM DIOXIDE 
ALPHA-TOCOPHEROL ACETATE 
WATER 
Packaging
#Item CodePackage Description
1NDC:29784-191-021 APPLICATOR (APPLICATOR) in 1 BOX
1NDC:29784-191-0126 g in 1 APPLICATOR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C10/10/2012
Labeler - Profoot, Inc. (107570900)
Establishment
NameAddressID/FEIOperations
Concept Laboratories, Inc.962282612manufacture(29784-191)

 
Profoot, Inc.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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