FUNGACLEAR

Manufacturer
CANDICE NELMS, INC.
Effective date
2018-12-19
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:10:35

Label at a glance#

ProductFUNGACLEAR
Active ingredientOLEA EUROPAEA LEAF
Label structure10 sections

Indications and uses

■ Restoration of nails due to fungal infection. * These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.

Dosage and administration

Directions Using applicator, drop extract on top of and under nail area, allow for absorption to occur before continuing application. Apply 5 applications two times per day.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Olive Leaf HPUS 1X 7.9%

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Alcohol, Bai Shao, Chaparrel, Damiana, Gan Jiang, Hai Tong Pi, Hong Hua, Jin Yin Hua, Jing Jie, Ku Shen, Lavender, Lemongrass, Long Dan Cao, Rosehips, Rou Gui, Tao Ren, White Sage Leaf

Purpose

OTC - PURPOSE SECTION

Active Ingredients--------Purpose
Olive Leaf .....................Redness, Discoloration, Anti-itch

The letters HPUS indicate ingredients officially included in the Homeopathic Pharmacopoeia of the United States.

Keep Out of Reach of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

If product is swallowed, get medical help or contact a Poison Control Center.

Uses*

INDICATIONS & USAGE SECTION

■ Restoration of nails due to fungal infection.


* These statements are based upon traditional homeopathic practice.
They have not been reviewed by the Food and Drug Administration.

Warnings

WARNINGS SECTION

For external use only. Avoid Eyes.

Directions

DOSAGE & ADMINISTRATION SECTION

Directions

Using applicator, drop extract on top of and under nail area, allow for absorption to occur before continuing application. Apply 5 applications two times per day.

Do Not Use

OTC - DO NOT USE SECTION

Do not use if tamper evident seal is broken.

SPL UNCLASSIFIED SECTION


Aged extract to restore nails affects by fungal infection

THE ALCHEMIST COLLECTION
175 Wrenn St.
Tavernier. FL 33070
www.thealchemistcollection.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BoxBox

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71281-303-012020-01-31C16284748780-19d75b9d0-14e0-f424-e053-dadaa90a57ceFUNGACLEAR

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71281-303-01FUNGACLEAR1 in 1 BOXLIQUID11
71281-303-01FUNGACLEAR28 mL in 1 BOTTLE, DROPPERLIQUID281

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71281-303FUNGACLEAR (OLIVE LEAF) LIQUID [CANDICE NELMS, INC.]1Legacy NDC, 2 package rows20181220_7d677c7c-e78e-2e6e-e053-2991aa0a9609.zip

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71281-30371281-303-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

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
7d677f4a-1251-a7b5-e053-2a91aa0a1b6a7d677c7c-e78e-2e6e-e053-2991aa0a96092018-12-19WarningsExact identifier
spl id: 7d677f4a-1251-a7b5-e053-2a91aa0a1b6a
spl set id: 7d677c7c-e78e-2e6e-e053-2991aa0a9609

Reported adverse events (FAERS/openFDA)#

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