FDA.reportPublic FDA data

Medessence Plus

Manufacturer
Deep Cover Systems LLC | Gar Laboratories
Effective date
2010-01-26
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 02:02:11

Label at a glance#

ProductMedessence Plus Homeopathic Nail
Active ingredientTHUJA OCCIDENTALIS TWIG, ANTIMONY TRISULFIDE, DIOSCOREA VILLOSA EXTRACT, GRAPHITE, SILICON DIOXIDE, SODIUM BORATE, CINNAMON
Label structure6 sections

Label contents#

Full prescribing information#

INACTIVE INGREDIENT SECTION

Inactive Ingredients:

Polysorbate 20, Melaleuca Artenrifolia (Tea Trea) Leaf Oil, Caprylic Acid, Citrus Grandis (Grapefruit) Seed Extract, Alpha-Arbutin, Capric Acid, Arctostaphylos Uva Ursi Leaf Extract, Pinus Pinaster Bark Extract, Citrus Limonum Seed Oil, Peppermint Oil, Sugar Cane Extract, Lauric Acid, Undecylenoyl Phenylalnine, Salicylic Acid, Ethyl Nicotinate, Citric Acid

DESCRIPTION SECTION

Purpose:

Anti-fungal, anti-microbial

Brittle and out of shape nails

Inflamed nail matrix

nails discolored and deformed

white spots; in grown nails

pain and throbbing

swelling; disinfectant

Equal Volumes of each ingredient: 10C, 20C, 30C potency

Distributed By Deep Cover Systems LLC

8851 Boardroom Circle Ft Myers FL 33919

1-866-685-6245

www.deepcoversystem.com


WARNINGS SECTION

For External Use Only

Avoid contact with eyes.  If contact occurs flush with water.

Intended for adult use only. Do not use on children under 2 years of age unless directed by a doctor

If irritation occurs or if there is no improvement within 4 weeks, discontinue use and see your health care provider

INDICATIONS & USAGE SECTION

For Directions, uses and other information:

See the package insert



DOSAGE & ADMINISTRATION SECTION

Deep Cover Directions for Use:

1.  Remove old nail polish or other product from your finger and toe nails.

2.  Gently brush the Medessence PLUS Homeopathic Nail Solution over nails, nail tips and surrounding cuticles.

3.  Wait 2 minutes to allow the Medessence PLUS Homeopathic Nail Solution to work its way into your nails, nail beds and cuticles.

4.  Using a dry cotton ball or tissue, completely remove Medessence PLUS Homeopathic Nail Solution from your nails and the surrounding area.

5.  Next using the Primer PLUS Cover up, brush 1-2 coats onto your nails.  Once this is dry you can brush on two coats of any
fashionable Deep Cover nail color.

For Men or Women you can leave the Primer PLUS Cover up on for 5-7 days for a great healthy look and repeat regimen above (steps 1-5).

For Women After 5-7 days repeat regimen above (steps 1-5).


What do I need to get started?

1.  Medessence PLUS Homeopathic Nail Solution

2.  Dry cotton ball or tissue.

3.  The Primer PLUS Cover-up.

4.  Fashionable Deep Cover nail color of your choice.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Enter section text here


Medessence LabelMedessence Label

Medessence InsertMedessence Insert

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50125-001-102019-10-21C16284748780-1956f9ecf-bdab-621f-e053-dbdaa90a74ad67251877-00a8-4ffb-9538-942c69016f40

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50125-001-10Medessence PlusHomeopathic Nail10 mL in 1 PACKETSOLUTION106

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50125-001MEDESSENCE PLUS HOMEOPATHIC NAIL (THUJA OCCIDENTALIS, ANTIMONIUM CRUDUM) SOLUTION [DEEP COVER SYSTEMS LLC]6Legacy NDC, 1 package rows20100202_67251877-00a8-4ffb-9538-942c69016f40.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ANTIMONY TRISULFIDEACTIVE INGREDIENTF79059A38U6
CINNAMONACTIVE INGREDIENT5S29HWU6QB6
DIOSCOREA VILLOSA EXTRACTACTIVE INGREDIENTIWY3IWX2G86
GRAPHITEACTIVE INGREDIENT4QQN74LH4O6
SILICON DIOXIDEACTIVE INGREDIENTETJ7Z6XBU46
SODIUM BORATEACTIVE INGREDIENT91MBZ8H3QO6
THUJA OCCIDENTALIS TWIGACTIVE INGREDIENT1NT28V93976
ANTIMONYACTIVE MOIETY9IT35J3UV36
BORIC ACIDACTIVE MOIETYR57ZHV85D46
CINNAMONACTIVE MOIETY5S29HWU6QB6
DIOSCOREA VILLOSA EXTRACTACTIVE MOIETYIWY3IWX2G86
GRAPHITEACTIVE MOIETY4QQN74LH4O6
SILICON DIOXIDEACTIVE MOIETYETJ7Z6XBU46
THUJA OCCIDENTALIS TWIGACTIVE MOIETY1NT28V93976

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50125-00150125-001-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
THUJA OCCIDENTALIS TWIG1NT28V9397ACTIB
ANTIMONY TRISULFIDEF79059A38UACTIB
DIOSCOREA VILLOSA EXTRACTIWY3IWX2G8ACTIB
GRAPHITE4QQN74LH4OACTIB
SILICON DIOXIDEETJ7Z6XBU4ACTIB
SODIUM BORATE91MBZ8H3QOACTIB
CINNAMON5S29HWU6QBACTIB

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
d7e65c45-74f4-45bc-bbba-3f30166aad4f67251877-00a8-4ffb-9538-942c69016f402010-01-26WarningsExact identifier
spl id: d7e65c45-74f4-45bc-bbba-3f30166aad4f
spl set id: 67251877-00a8-4ffb-9538-942c69016f40

Reported adverse events (FAERS/openFDA)#

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