The following Structured Product Label (SPL) was submitted to the FDA by Deep Cover Systems Llc for the product Medessence Plus (NDC 50125-001). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding inactive ingredient, description, warnings, indications & usage, dosage & administration, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
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
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
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
For Directions, uses and other information:
See the package insert
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).
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Medessence Label (Medessence1)
* Please review the disclaimer below.
