FDA.reportPublic FDA data

CRYSTAL FLUSH

Manufacturer
Triple Point Group, LLC
Effective date
2021-03-20
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:39:06

Label at a glance#

ProductCRYSTAL FLUSH Maximum Strength Anti-Fungal Formula
Active ingredientUNDECYLENIC ACID
Label structure7 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 on children under two years of age. DO NOT USE on diaper rash.

When using this product avoid contact with eyes.

Stop use and ask a doctor if

  • irritation occurs
  • there is no improvement within four weeks.

If pregnant or breast-feeding, ask a health professional before use.

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

  • 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 LABEL.PRINCIPAL DISPLAY PANEL

01b LBL_Crystal Flush_15mL01b LBL_Crystal Flush_15mL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
998329undecylenic acid 25 % Topical SolutionPSN1
998329undecylenic acid 250 MG/ML Topical SolutionSCD1
998329undecylenic acid 25 % Topical SolutionSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80569-184-152023-01-30C16284748780-1f386c649-e5a6-0266-e053-dadaa90a7c1aCRYSTAL FLUSH Maximum Strength Anti-Fungal Formula

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80569-184-15CRYSTAL FLUSHMaximum Strength Anti-Fungal Formula15 mL in 1 BOTTLESOLUTION151

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80569-184CRYSTAL FLUSH MAXIMUM STRENGTH ANTI-FUNGAL FORMULA (UNDECYLENIC ACID) SOLUTION [TRIPLE POINT GROUP, LLC]1Legacy NDC, 1 package rows20210323_84f82b4a-3784-4ce0-89f5-7ee7aae2ca58.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
80569-18480569-184-15

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
UNDECYLENIC ACIDK3D86KJ24NACTIB
CITRONELLA OILQYO8Q067D0IACT
LAVENDER OILZBP1YXW0H8IACT
TEA TREE OILVIF565UC2GIACT
ALMOND OIL66YXD4DKO9IACT
JOJOBA OIL724GKU717MIACT
CLOVE OIL578389D6D0IACT
.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
973c3d59-0c3c-40de-a0de-147f0ca6a11f84f82b4a-3784-4ce0-89f5-7ee7aae2ca582021-03-20WarningsExact identifier
spl id: 973c3d59-0c3c-40de-a0de-147f0ca6a11f
spl set id: 84f82b4a-3784-4ce0-89f5-7ee7aae2ca58

Reported adverse events (FAERS/openFDA)#

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