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ProClearz Maximum Strength Fungal Shield Brush-on Antifungal

Medically reviewed on February 14, 2017

Dosage form: solution
Ingredients: TOLNAFTATE 10mg in 1mL
Labeler: Profoot, Inc.
NDC Code: 29784-181

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 Maximum Strength Fungal Sheild Anti-Fungal Brush-On Solution

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

Extremely flammable

  • keep away from fire or flame

When using this product
  • avoid contact with the eyes
  • if contact occurs rinse thoroughly with water

Stop use and ask a doctor if
  • 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 15º-30ºC (59º-86ºF)

Inactive ingredients

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

ProClearz Anti-Fungal Shield

1% Tolnaftate

Anti-fungal Liquid

30 ml

PROCLEARZ  MAXIMUM STRENGTH FUNGAL SHIELD BRUSH-ON ANTIFUNGAL
tolnaftate solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:29784-181
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TOLNAFTATE (TOLNAFTATE) TOLNAFTATE10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ACETONE 
ALOE VERA LEAF 
.ALPHA.-TOCOPHEROL ACETATE 
PROPYLENE GLYCOL 
WATER 
Packaging
#Item CodePackage Description
1NDC:29784-181-021 BOTTLE, WITH APPLICATOR in 1 BOX
1NDC:29784-181-0130 mL in 1 BOTTLE, WITH APPLICATOR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C10/22/2012
Labeler - Profoot, Inc. (107570900)
Establishment
NameAddressID/FEIOperations
Emilia Resources, LLC079378421manufacture(29784-181)
Establishment
NameAddressID/FEIOperations
Concept Laboratories, Inc.962282612manufacture(29784-181)

 
Profoot, Inc.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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