ProClearz Anti-Fungal Pen Maximum Strength - Drug Facts

ProClearz by

Drug Labeling and Warnings

ProClearz by is a Otc medication manufactured, distributed, or labeled by Profoot, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PROCLEARZ  MAXIMUM STRENGTH ANTI-FUNGAL PEN- tolnaftate liquid 
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 Anti-Fungal Pen Maximum Strength - Drug Facts

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

PROCLEARZ   MAXIMUM STRENGTH ANTI-FUNGAL PEN
tolnaftate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 29784-189
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV)	TOLNAFTATE	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
DIMETHICONE (UNII: 92RU3N3Y1O)
DMDM HYDANTOIN (UNII: BYR0546TOW)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
METHYLPARABEN (UNII: A2I8C7HI9T)
MINERAL OIL (UNII: T5L8T28FGP)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 29784-189-02	1 in 1 BOX	10/23/2012	02/29/2020
1	NDC: 29784-189-01	3.25 mL in 1 APPLICATOR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	10/23/2012	02/29/2020

Labeler - Profoot, Inc. (107570900)

Revised: 12/2019

Document Id: 99d3b8e3-7516-931b-e053-2995a90a2bc2

34390-5

Set id: 66ff94ef-2739-411b-942b-ae2f33646f66

Version: 16

Effective Time: 20191216