Label: MEDESSENCE PLUS HOMEOPATHIC NAIL - thuja occidentalis twig, antimony trisulfide, dioscorea villosa extract, graphite, silicon dioxide, sodium borate and cinnamon solution
- NDC Code(s): 50125-001-10
- Packager: Deep Cover Systems LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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- INACTIVE INGREDIENT
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 AcidClose
Brittle and out of shape nails
Inflamed nail matrix
nails discolored and deformed
white spots; in grown nails
pain and throbbing
Equal Volumes of each ingredient: 10C, 20C, 30C potency
Distributed By Deep Cover Systems LLC
8851 Boardroom Circle Ft Myers FL 33919
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
For Directions, uses and other information:
See the package insert
- DOSAGE & ADMINISTRATION
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.
- PRINCIPAL DISPLAY PANEL
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- INGREDIENTS AND APPEARANCE
MEDESSENCE PLUS HOMEOPATHIC NAIL
thuja occidentalis, antimonium crudum solution
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50125-001 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength THUJA OCCIDENTALIS TWIG (UNII: 1NT28V9397) (THUJA OCCIDENTALIS TWIG - UNII:1NT28V9397) THUJA OCCIDENTALIS TWIG 10 [hp_X] in 10 mL ANTIMONY TRISULFIDE (UNII: F79059A38U) (ANTIMONY - UNII:9IT35J3UV3) ANTIMONY TRISULFIDE 10 [hp_X] in 10 mL DIOSCOREA VILLOSA EXTRACT (UNII: IWY3IWX2G8) (DIOSCOREA VILLOSA EXTRACT - UNII:IWY3IWX2G8) DIOSCOREA VILLOSA EXTRACT 10 [hp_X] in 10 mL GRAPHITE (UNII: 4QQN74LH4O) (GRAPHITE - UNII:4QQN74LH4O) GRAPHITE 10 [hp_X] in 10 mL SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE 10 [hp_X] in 10 mL SODIUM BORATE (UNII: 91MBZ8H3QO) (BORIC ACID - UNII:R57ZHV85D4) SODIUM BORATE 10 [hp_X] in 10 mL CINNAMON (UNII: 5S29HWU6QB) (CINNAMON - UNII:5S29HWU6QB) CINNAMON 10 [hp_X] in 10 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50125-001-10 10 mL in 1 PACKET Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 05/01/2009 Labeler - Deep Cover Systems LLC (011636505) Registrant - Deep Cover Systems LLC (011636505) Establishment Name Address ID/FEI Business Operations Deep Cover Systems LLC 011636505 relabel Establishment Name Address ID/FEI Business Operations Gar Laboratories 074933615 manufacture