PROCLEARZ FUNGI-CIDE PM- tolnaftate cream 
Profoot, Inc.

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.

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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

CartonLabelCarton

PROCLEARZ  FUNGI-CIDE PM
tolnaftate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:29784-191
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
ELETTARIA CARDAMOMUM WHOLE (UNII: KH2S76267N)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
LAURETH-7 (UNII: Z95S6G8201)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
MINERAL OIL (UNII: T5L8T28FGP)  
POLYACRYLAMIDE (1500 MW) (UNII: 5D6TC4BRWV)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:29784-191-021 in 1 BOX10/10/201209/27/2018
1NDC:29784-191-0126 g in 1 APPLICATOR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C10/10/201209/27/2018
Labeler - Profoot, Inc. (107570900)
Establishment
NameAddressID/FEIBusiness Operations
Concept Laboratories, Inc.962282612manufacture(29784-191)

Revised: 9/2018
 
Profoot, Inc.