FDA.reportPublic FDA data

CRYSTAL FLUSH

Manufacturer
Triple Point Group, LLC
Effective date
2021-04-28
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:40:10

Label at a glance#

ProductCRYSTAL FLUSH Maximum Strength Anti-Fungal Formula
Active ingredientTOLNAFTATE
Label structure8 sections

Indications and uses

Effective treatment for athlete's foot (tinea pedis) and ringworm (tinea corporis). For the effective relief of itching, scaling, cracking and discomforts which may accompany these conditions.

Dosage and administration

Clean or wash the affected area and dry throughly. Apply a thin layer of the product over the affected area twice daily (morning and night) or as directed by doctor. For athletes foot, pay special attention to space between 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. For jock itch, use daily for 2 weeks. If condi...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Tolnaftate 1%

Purpose:

OTC - PURPOSE SECTION

Anti-fungal

Uses:

INDICATIONS & USAGE SECTION

Effective treatment for athlete's foot (tinea pedis) and ringworm (tinea corporis). For the effective relief of itching, scaling, cracking and discomforts which may accompany these conditions.

Warnings:

WARNINGS SECTION

For external use only.

  • Avoid contact with the eyes.
  • Do not use on children under 2 years of age unless directed by a doctor.
  • If treating athlete's foot and ringworms: Stop use and consult a doctor if irritation occurs or if there is no improvement within 4 weeks.
  • If swallowed, get medical help or contact a Poison Control Center right away.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep this and all drugs out of the reach of children.

Directions:

DOSAGE & ADMINISTRATION SECTION

Clean or wash the affected area and dry throughly. Apply a thin layer of the product over the affected area twice daily (morning and night) or as directed by doctor. For athletes foot, pay special attention to space between 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. For jock itch, use daily for 2 weeks. If condition persists longer, consult a doctor. This product is not effective on the scalp or nails. Supervise children in the use of this product.

Inactive ingredients:

INACTIVE INGREDIENT SECTION

Prunus Amygdalus Dulcis (Sweet Almond) Oil, Cymbopogan Nardus (Citronella) Oil, Lavandula Angustifolia (Lavender) Oil, Melaleuca Alternifolia (Tea Tree) Oil, Simmondsia Chinensis (Jojoba) Oil, Syzygium Aromaticum (Clovebud) Oil, Azadirachta Indica (Neem) oil, Tocopheryl Acetate (Vitamin E).

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

01b LBL_Crystal Flush w-Tolnaftate01b LBL_Crystal Flush w-Tolnaftate

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
313423tolnaftate 1 % Topical SolutionPSN2
313423tolnaftate 10 MG/ML Topical SolutionSCD2
313423tolnaftate 1 % Topical SolutionSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80569-101-152023-01-30C16284748780-1f386c649-bb70-0266-e053-dadaa90a7c1aCRYSTAL FLUSH Maximum Strength Anti-Fungal Formula

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80569-101-15CRYSTAL FLUSHMaximum Strength Anti-Fungal Formula15 mL in 1 BOTTLESOLUTION152

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80569-101CRYSTAL FLUSH MAXIMUM STRENGTH ANTI-FUNGAL FORMULA (TOLNAFTATE) SOLUTION [TRIPLE POINT GROUP, LLC]2Legacy NDC, 1 package rows20210505_c0100085-ed24-4e63-9489-e31801fd262e.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80569-10180569-101-15

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
TOLNAFTATE06KB629TKVACTIB
ALMOND OIL66YXD4DKO9IACT
CITRONELLA OILQYO8Q067D0IACT
LAVENDER OILZBP1YXW0H8IACT
TEA TREE OILVIF565UC2GIACT
JOJOBA OIL724GKU717MIACT
CLOVE OIL578389D6D0IACT
AZADIRACHTA INDICA SEED OIL4DKJ9B3K2TIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT

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
77e5b8f8-1264-4df0-8bcb-eb59378b423fc0100085-ed24-4e63-9489-e31801fd262e2021-04-28WarningsExact identifier
spl id: 77e5b8f8-1264-4df0-8bcb-eb59378b423f
spl set id: c0100085-ed24-4e63-9489-e31801fd262e

Reported adverse events (FAERS/openFDA)#

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