NDC 61096-1022 Hair And Nail Tonic

Avena, Dna, Elaeis, Glandula Suprarenalis Suis, Hamamelis, Hepar Suis, Kali Sulph, Nat Mur, Nicotinamidum, Phosphoricum Ac, Pituitarum Posterium, Riboflavinum, Thiaminum Hydrochloricum, Thuja Occ, Thyroidinum, Urtica Ur.

NDC Product Code 61096-1022

NDC CODE: 61096-1022

Proprietary Name: Hair And Nail Tonic What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Avena, Dna, Elaeis, Glandula Suprarenalis Suis, Hamamelis, Hepar Suis, Kali Sulph, Nat Mur, Nicotinamidum, Phosphoricum Ac, Pituitarum Posterium, Riboflavinum, Thiaminum Hydrochloricum, Thuja Occ, Thyroidinum, Urtica Ur. What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • This product is used to treat dryness inside the nose (nasal passages). It helps add moisture inside the nose to dissolve and soften thick or crusty mucus. In babies and young children with stuffy noses who cannot blow their noses, using this product helps to make the mucus easier to remove with a nasal bulb syringe. This helps relieve stuffiness and makes breathing easier. This product contains a purified gentle salt solution (also called saline or sodium chloride solution). It does not contain any medication.
  • Niacinamide (nicotinamide) is a form of vitamin B3 (niacin) and is used to prevent and treat niacin deficiency (pellagra). Niacin deficiency can cause diarrhea, confusion (dementia), tongue redness/swelling, and peeling red skin. Niacinamide is often used instead of niacin because it causes fewer side effects (e.g., flushing). Unlike niacin, niacinamide does not help correct blood fat levels and cannot be substituted for niacin if you are being treated for a blood fat problem (e.g., high cholesterol). Niacin deficiency may happen as a result of poor diet, certain medical conditions (e.g., alcohol abuse, malabsorption syndrome, Hartnup disease), or long-term use of certain medications (e.g., isoniazid). It is best to get your vitamins from healthy foods. A multivitamin may be recommended by your doctor instead of niacinamide because poor diet usually causes deficiencies in more than one vitamin. Vitamins help to support the body's ability to make and break down natural substances (metabolism) and are needed for good health.

NDC Code Structure

  • 61096 - Eight And Company L.l.c

NDC 61096-1022-1

Package Description: 1 BOTTLE, SPRAY in 1 CARTON > 41 mL in 1 BOTTLE, SPRAY

NDC Product Information

Hair And Nail Tonic with NDC 61096-1022 is a a human over the counter drug product labeled by Eight And Company L.l.c. The generic name of Hair And Nail Tonic is avena, dna, elaeis, glandula suprarenalis suis, hamamelis, hepar suis, kali sulph, nat mur, nicotinamidum, phosphoricum ac, pituitarum posterium, riboflavinum, thiaminum hydrochloricum, thuja occ, thyroidinum, urtica ur.. The product's dosage form is liquid and is administered via oral form.

Labeler Name: Eight And Company L.l.c

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Hair And Nail Tonic Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • HERRING SPERM DNA 12 [hp_X]/41mL
  • PORK LIVER 6 [hp_X]/41mL
  • POTASSIUM SULFATE 30 [hp_C]/41mL
  • SODIUM CHLORIDE 200 [hp_C]/41mL
  • NIACINAMIDE 6 [hp_X]/41mL
  • PHOSPHORIC ACID 4 [hp_X]/41mL
  • RIBOFLAVIN 8 [hp_X]/41mL
  • URTICA URENS 4 [hp_X]/41mL

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.
  • Oral - Administration to or by way of the mouth.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Eight And Company L.l.c
Labeler Code: 61096
Marketing Category: UNAPPROVED HOMEOPATHIC - What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 03-08-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Hair And Nail Tonic Product Label Images

Hair And Nail Tonic Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Otc - Active Ingredient

Active Ingredients: Avena sativa 3X, DNA 12X, Elaeis guineensis 10X, Glandula suprarenalis suis 30C, Hamamelis virginiana 3X, Hepar suis 6X, Kali sulphuricum 30C, Natrum muriaticum 200C, Nicotinamidum 6X, Phosphoricum acidum 3X, Pituitarum posterium 8X, Riboflavinum 6X, Thiaminum hydrochloricum 6X, Thuja occidentalis 200C, Thyroidinum 30C, Urtica urens 3X.


Warnings: If symptoms persist or worsen, stop use and seek advice of physician. If pregnant or breast-feeding, ask a health care professional before use. Keep out of reach of children. Contains alcohol, in case of overdose, get medical help or contact a Poison Control Center right away.

Otc - Keep Out Of Reach Of Children

​Keep out of reach of children.

Otc - Purpose

  • Temporary relief of:dull, slow growing hairbrittle nailsdry scalp

Dosage & Administration

  • Directions:For adults only, 2 sprays under the tongue 3 times per day.

Other Safety Information

Other Information: Do not use if the transparent seal around spray bottle is broken or missing.

Inactive Ingredient

Inactive Ingredients: Glycerin 10%, v/v, non-GMO organic alcohol 9% v/v and purified water.

Indications & Usage

Temporary relief of:° dull, slow growing hair° brittle nails° dry scalp° natural° gluten free° no artificial flavors or colors° no known negative side effects° no known negative drug interactions

* Please review the disclaimer below.