FDA.reportPublic FDA data

ProClearz Laser Spray Antifungal

Manufacturer
Rooftop Consumer Health, inc
Effective date
2026-01-29
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:35:29

Label at a glance#

ProductProClearz Laser Antifungal
Active ingredientTOLNAFTATE
Label structure8 sections

Indications and uses

proven clinically effective in the treatment of most athlete’s foot (tinea pedis) and ringworm (tinea corporis) helps prevent most athlete’s foot with daily use for effective relief of itching, burning, and cracking

Dosage and administration

wash affected area and dry thoroughly shake can well and spray a thin layer over affected area twice daily (morning and night) 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 changes shoes and socks at least once daily use daily for 4 weeks; if condition persists longer, ask a doctor to prevent athlete’s foo...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Tolnaftate 1%

Purpose

OTC - PURPOSE SECTION

Antifungal

Uses

INDICATIONS & USAGE SECTION

  • proven clinically effective in the treatment of most athlete’s foot (tinea pedis) and ringworm (tinea corporis)
  • helps prevent most athlete’s foot with daily use
  • for effective relief of itching, burning, and cracking

Warnings

WARNINGS SECTION

For external use only.

Flammable:Do not use while smoking or near heat or flame

Do not use

OTC - DO NOT USE SECTION

on children under 2 years of age unless directed by a doctor.

When using this product

OTC - WHEN USING SECTION

  • Avoid contact with eyes
  • Use only as directed. Intentional misuse by deliberately concetrating and inhaling contents can be harmful or fatal
  • Contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120°F

Stop use and ask doctor if

OTC - STOP USE SECTION

  • irritation occurs
  • there is no improvement within 4 weeks

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • wash affected area and dry thoroughly
  • shake can well and spray a thin layer over affected area twice daily (morning and night)
  • 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 changes shoes and socks at least once daily
  • use daily for 4 weeks; if condition persists longer, ask a doctor
  • to prevent athlete’s foot apply once or twice daily (morning and/or night)
  • this product is not effective on the scalp or nails

Other information

SPL UNCLASSIFIED SECTION

store between 20° to 25°C (68° to 77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

butylated hydroxytoluene, isobutane, PPG-12-buteth-16, SD alcohol 40-B (30% v/v)

Questions or comments?

OTC - QUESTIONS SECTION

www.rooftopch.com cservice@rooftopch.com

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label0Label0

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2700695Proclearz 1 % Topical SprayPSN3
313421tolnaftate 1 % Topical SprayPSN3
2700695tolnaftate 10 MG/ML Topical Spray [Proclearz]SBD3
313421tolnaftate 10 MG/ML Topical SpraySCD3
2700695Proclearz 1 % Topical SpraySY3
2700695Proclearz 10 MG/ML Topical SpraySY3
313421tolnaftate 1 % Topical SpraySY3

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130080376515407GTIN-13: 0080376515407
EAN-13: 0080376515407
GTIN-12: 080376515407
UPC-A: 080376515407
GTIN storage (14 digits): 00080376515407		Label0.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
29784-183-01ProClearz Laser Antifungal85 g in 1 BOTTLE, SPRAYLIQUID853

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
29784-18329784-183-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
ISOBUTANEBXR49TP611IACT
PPG-12-BUTETH-1658CG7042J1IACT
TOLNAFTATE06KB629TKVACTIB
ALCOHOL3K9958V90MIACT

Source Document#

Source XML

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 Laser AntifungalTOLNAFTATERooftop Consumer Health, inc53648135-7b79-4775-993b-48fa1298b7472026-01-29WarningsExact identifier
ndc (package): 29784-183-01
ndc (product): 29784-183
ndc11 (package): 29784018301
spl id: 4988109f-6e4b-0acb-e063-6294a90a419e
spl set id: 53648135-7b79-4775-993b-48fa1298b747

Reported adverse events (FAERS/openFDA)#

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