FDA.reportPublic FDA data

FLUSH Maximum Strength Antifungal formula

Manufacturer
Triple Point Group, LLC
Effective date
2023-11-11
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 00:00:00

Label at a glance#

ProductFLUSH Maximum Strength Antifungal formula
Active ingredientUNDECYLENIC ACID
Label structure6 sections

Indications and uses

For cure of most: • ringworm (tinea corporis) • athlete's foot (tinea pedis). For the relief of: • itching• scaling • cracking • burning • redness • soreness • irritation and discomforts which may accompany these conditions. 

Dosage and administration

Clean and dry affected area with soap and water and dry throughly. Apply a thin layer to the affected area twice daily (morning and night) or as directed by physician. For athletes foot, pay special attention to the space between the toes, and wear well-fitting ventilated shoes and socks. For athlete's foot and ringworm. If Conditions persists for longer, consult a physician. Intended for use typically by healthy ...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Undecylenic Acid 25%

Purpose

OTC - PURPOSE SECTION

Anti-fungal

Uses:

INDICATIONS & USAGE SECTION

For cure of most: • ringworm (tinea corporis) • athlete's foot (tinea pedis). For the relief of: • itching• scaling • cracking • burning • redness • soreness • irritation and discomforts which may accompany these conditions. 

Warnings:

WARNINGS SECTION

For external use only.

Ask a doctor before use

OTC - ASK DOCTOR SECTION

on children under two years of age

DO NOT USE

OTC - DO NOT USE SECTION

on diaper rash. 

When using this product

OTC - WHEN USING SECTION

avoid contact with eyes.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • irritation occurs
  • there is no improvement within four 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. 

If pregnant or breast-feeding, 

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Directions:

DOSAGE & ADMINISTRATION SECTION

  • Clean and dry affected area with soap and water and dry throughly.
  • Apply a thin layer to the affected area twice daily (morning and night) or as directed by physician.
  • For athletes foot, pay special attention to the space between the toes, and wear well-fitting ventilated shoes and socks. For athlete's foot and ringworm. If Conditions persists for longer, consult a physician.
  • Intended for use typically by healthy adults only. Persons under the age of 18, or those with highly sensitive or allergic skin should use only as directed by physician.
  • This product is not meant to be applied directly to the Scalp or nails.

Other ingredients:

INACTIVE INGREDIENT SECTION

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

Package Labeling

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BottleBottle

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
998329undecylenic acid 25 % Topical SolutionPSN6
998329undecylenic acid 250 MG/ML Topical SolutionSCD6
998329undecylenic acid 25 % Topical SolutionSY6

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80569-084-15FLUSH Maximum Strength Antifungal formula15 mL in 1 BOTTLE, GLASSLIQUID156

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80569-084FLUSH MAXIMUM STRENGTH ANTIFUNGAL FORMULA (UNDECYLENIC ACID) LIQUID [TRIPLE POINT GROUP, LLC]6Current NDC, Legacy NDC, 1 package rows20231112_1d9e56ef-c7c9-4aff-ab9e-b163e566e3d5.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80569-08480569-084-15

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
CITRONELLA OILQYO8Q067D0IACT
LAVENDER OILZBP1YXW0H8IACT
TEA TREE OILVIF565UC2GIACT
ALMOND OIL66YXD4DKO9IACT
JOJOBA OIL724GKU717MIACT
CLOVE OIL578389D6D0IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
UNDECYLENIC ACIDK3D86KJ24NACTIB

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
FLUSH Maximum Strength Antifungal formulaUNDECYLENIC ACIDTriple Point Group, LLC1d9e56ef-c7c9-4aff-ab9e-b163e566e3d52023-11-11WarningsExact identifier
ndc (package): 80569-084-15
ndc (product): 80569-084
ndc11 (package): 80569008415
spl id: 09e240de-0009-c20f-e063-6294a90a09c4
spl set id: 1d9e56ef-c7c9-4aff-ab9e-b163e566e3d5

Reported adverse events (FAERS/openFDA)#

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