FDA.reportPublic FDA data

ProClearz Maximum Strength Fungal Sheild Anti-Fungal Brush-On Solution

Manufacturer
Rooftop Consumer Health, Inc.
Effective date
2026-03-02
Label type
HUMAN OTC DRUG LABEL
Version
38
Source
full-release
Hydrated at
2026-06-01 01:48:23

Label at a glance#

ProductProClearz Maximum Strength Fungal Shield Brush-on Antifungal
Active ingredientTOLNAFTATE
Label structure12 sections

Indications and 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

Dosage and administration

■ 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 athl...

Storage and handling

store at room temperature 15º-30ºC (59º-86ºF)

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 athlete'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

GENERAL PRECAUTIONS SECTION

Extremely flammable

  • keep away from fire or flame

When using this product

OTC - WHEN USING SECTION

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

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • irritation occurs or if there is no improvement in 4 weeks

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

■ 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

STORAGE AND HANDLING SECTION

  • store at room temperature 15º-30ºC (59º-86ºF)

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

updated outer boxupdated outer boxDrug Facts PanelDrug Facts PanelUpated Inner LabelUpated Inner Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1311221ProClearz 1 % Topical SolutionPSN38
313423tolnaftate 1 % Topical SolutionPSN38
1311221tolnaftate 10 MG/ML Topical Solution [Proclearz]SBD38
313423tolnaftate 10 MG/ML Topical SolutionSCD38
1311221Proclearz 1 % Topical SolutionSY38
1311221Proclearz 10 MG/ML Topical SolutionSY38
313423tolnaftate 1 % Topical SolutionSY38

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
29784-181-01ProClearzMaximum Strength Fungal Shield Brush-on Antifungal30 mL in 1 BOTTLE, WITH APPLICATORSOLUTION3038
29784-181-02ProClearzMaximum Strength Fungal Shield Brush-on Antifungal1 in 1 BOXSOLUTION138

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
TOLNAFTATEACTIVE INGREDIENT06KB629TKV6
TOLNAFTATEACTIVE MOIETY06KB629TKV6
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L06
ACETONEINACTIVE INGREDIENT1364PS73AF6
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0X6
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V36
WATERINACTIVE INGREDIENT059QF0KO0R6

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
29784-18129784-181-01, 29784-181-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACETONE1364PS73AFIACT
ALOE VERA LEAFZY81Z83H0XIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
TOLNAFTATE06KB629TKVACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
372026-01-29monthly-update2026-06-03 17:53:22

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 1 · 15 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
.ALPHA.-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0FILM / BUCCAL0.09 mgExact identifier — unii candidate
9 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0CAPSULE / ORAL2 mgExact identifier — unii candidate
9 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0TABLET / ORAL0.5 mgExact identifier — unii candidate
9 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0TABLET / ORAL0.5 mgExact identifier — unii candidate
9 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0CAPSULE / ORAL2 mgExact identifier — unii candidate
9 equally ranked IID candidates
ACETONEACETONE1364PS73AFTABLET, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
3 equally ranked IID candidates
ACETONEACETONE1364PS73AFTABLET, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
3 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0FILM / BUCCAL0.09 mgExact identifier — unii candidate
9 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION / TOPICAL4886 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0FILM / BUCCAL0.09 mgExact identifier — unii candidate
9 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION / TOPICAL4886 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
ACETONEACETONE1364PS73AFTABLET, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
3 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0TABLET / ORAL0.5 mgExact identifier — unii candidate
9 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION / TOPICAL4886 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0CAPSULE / ORAL2 mgExact identifier — unii candidate
9 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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ProClearz Maximum Strength Fungal Shield Brush-on AntifungalTOLNAFTATERooftop Consumer Health, Inc.4d451e87-c25b-49cf-92b8-747b053930c22026-03-02WarningsExact identifier
ndc (package): 29784-181-02
ndc (package): 29784-181-01
ndc (product): 29784-181
ndc11 (package): 29784018102
ndc11 (package): 29784018101
spl id: 4c0c1702-95ab-d4ad-e063-6294a90afb7c
spl set id: 4d451e87-c25b-49cf-92b8-747b053930c2

Reported adverse events (FAERS/openFDA)#

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