ProClearz

Manufacturer: Profoot, Inc.
Effective date: 2019-12-16
Label type: HUMAN OTC DRUG LABEL
Version: 16
Source: legacy-cache
Hydrated at: 2026-08-01 23:51:10

Label at a glance#

ProductProClearz Maximum Strength Anti-fungal Pen

Active ingredientTOLNAFTATE

Label structure11 sections

Indications and 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

Dosage and administration

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 i...

Contacts and useful links#

PhoneLabel contact1.800.526.FOOT

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Tolnaftate 1%

Purpose

OTC - PURPOSE SECTION

Anti-fungal

Uses

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

For external use only

do not use on children under 2 years of age unless directed by a doctor

OTC - WHEN USING SECTION

When using this product

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

OTC - ASK DOCTOR SECTION

Stop use and ask doctor if

if irritation occurs or if there is no improvement within 4 weeks

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

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

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

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

Image of Label and Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
TOLNAFTATE	ACTIVE INGREDIENT	06KB629TKV	8
TOLNAFTATE	ACTIVE MOIETY	06KB629TKV	8
.ALPHA.-TOCOPHEROL ACETATE	INACTIVE INGREDIENT	9E8X80D2L0	8
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	8
ASCORBIC ACID	INACTIVE INGREDIENT	PQ6CK8PD0R	8
CETOSTEARYL ALCOHOL	INACTIVE INGREDIENT	2DMT128M1S	8
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	8
DMDM HYDANTOIN	INACTIVE INGREDIENT	BYR0546TOW	8
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	8
GLYCERYL STEARATE SE	INACTIVE INGREDIENT	FCZ5MH785I	8
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	8
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	8
POLYOXYL 20 CETOSTEARYL ETHER	INACTIVE INGREDIENT	YRC528SWUY	8
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	8
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	8
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	8
VITAMIN A PALMITATE	INACTIVE INGREDIENT	1D1K0N0VVC	8
WATER	INACTIVE INGREDIENT	059QF0KO0R	8

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 18 matching rows.

ProClearz Maximum Strength Anti-fungal Pen
Tolnaftate
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

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
29784-189	29784-189-01, 29784-189-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
ALOE VERA LEAF	ZY81Z83H0X	IACT
ASCORBIC ACID	PQ6CK8PD0R	IACT
CETOSTEARYL ALCOHOL	2DMT128M1S	IACT
DIMETHICONE	92RU3N3Y1O	IACT
DMDM HYDANTOIN	BYR0546TOW	IACT
GLYCERIN	PDC6A3C0OX	IACT
GLYCERYL STEARATE SE	FCZ5MH785I	IACT
METHYLPARABEN	A2I8C7HI9T	IACT
MINERAL OIL	T5L8T28FGP	IACT
POLYOXYL 20 CETOSTEARYL ETHER	YRC528SWUY	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
PROPYLPARABEN	Z8IX2SC1OH	IACT
VITAMIN A PALMITATE	1D1K0N0VVC	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	IACT
WATER	059QF0KO0R	IACT
TOLNAFTATE	06KB629TKV	ACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 7 · 420 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SUPPOSITORY / VAGINAL	252 mg		Exact identifier — unii candidate 81 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	TABLET, CHEWABLE / ORAL		6 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	OINTMENT, AUGMENTED / TOPICAL		714 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	FILM / BUCCAL		1 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
CETOSTEARYL ALCOHOL	CETOSTEARYL ALCOHOL	2DMT128M1S	AEROSOL, FOAM / TOPICAL		21 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SUPPOSITORY / VAGINAL	227.9 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION / RECTAL	0.02 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	INJECTION / SUBCUTANEOUS	1.4 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	FILM, EXTENDED RELEASE / BUCCAL		34 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	CREAM / VAGINAL		3 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SYSTEM / TOPICAL		42 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION, CONCENTRATE / INTRAVENOUS	50.33 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 40 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION / OPHTHALMIC	0.02 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS	15 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS	0.8 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	TABLET, DELAYED RELEASE / ORAL		36 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE	.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	TABLET / ORAL	0.5 mg		Exact identifier — unii candidate 3 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION / NASAL	140 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	POWDER, FOR SUSPENSION / ORAL		297 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION / TOPICAL		24 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	CAPSULE, EXTENDED RELEASE / ORAL		120 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
POLYOXYL 20 CETOSTEARYL ETHER	POLYOXYL 20 CETOSTEARYL ETHER	YRC528SWUY	GEL / TOPICAL	2 %w/w		Exact identifier — unii candidate 7 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	OIL / TOPICAL	43.29 %v/v		Exact identifier — unii candidate 30 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SYRUP / ORAL		40 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION, SUSPENSION / SUBCUTANEOUS	0.02 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SPRAY / TOPICAL	0.2 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CREAM / TOPICAL		76000 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	GRANULE, FOR SUSPENSION / ORAL		143 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SPONGE / TOPICAL	40 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION / OPHTHALMIC	0.6 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SPONGE / TOPICAL	2 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	SUPPOSITORY, EXTENDED RELEASE / INTRAUTERINE	1 mg		Exact identifier — unii candidate 40 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	SHAMPOO, SUSPENSION / TOPICAL	3 %w/v		Exact identifier — unii candidate 40 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	GEL / OPHTHALMIC	0.88 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	FILM, EXTENDED RELEASE / TRANSDERMAL	NA		Exact identifier — unii candidate 40 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CAPSULE / ORAL		3487 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION, SOLUTION / INTRAMUSCULAR		45 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	FILM, EXTENDED RELEASE / TRANSDERMAL	306.2 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SHAMPOO / TOPICAL	8 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
ASCORBIC ACID	ASCORBIC ACID	PQ6CK8PD0R	CAPSULE, EXTENDED RELEASE / ORAL		17 mg	Exact identifier — unii candidate 25 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION / PERIDURAL	1 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	CREAM / TOPICAL		6 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION / INTRAVENOUS	0.13 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION / INTRALESIONAL	0.02 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SPRAY / NASAL		5 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SUPPOSITORY / VAGINAL	NA		Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	JELLY / NASAL	140 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION/ DROPS / OPHTHALMIC	0.05 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION / ORAL		32400 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION / AURICULAR (OTIC)	10 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	OINTMENT / OPHTHALMIC	0.05 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION / IONTOPHORESIS	0.1 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION, SOLUTION / INTRAVENOUS		45 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION / DENTAL	2 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	ENEMA / RECTAL	0.18 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	ELIXIR / ORAL	200 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CAPSULE, COATED PELLETS / ORAL	4.4 mg		Exact identifier — unii candidate 40 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION, SUSPENSION / INTRAMUSCULAR	0.02 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	OINTMENT / DENTAL	NA		Exact identifier — unii candidate 81 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
99d3b8e3-7516-931b-e053-2995a90a2bc2			66ff94ef-2739-411b-942b-ae2f33646f66	2019-12-16	Warnings	Exact identifier spl id: 99d3b8e3-7516-931b-e053-2995a90a2bc2 spl set id: 66ff94ef-2739-411b-942b-ae2f33646f66

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.