NDC 71946-020 Sulfur

Niacinamide, Adenosine

NDC Product Code 71946-020

NDC CODE: 71946-020

Proprietary Name: Sulfur 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: Niacinamide, Adenosine 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.

  • 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.
  • Drug uses not available

NDC Code Structure

NDC 71946-020-02

Package Description: 1 CONTAINER in 1 CARTON > 70 mL in 1 CONTAINER (71946-020-01)

NDC Product Information

Sulfur with NDC 71946-020 is a a human over the counter drug product labeled by Selenia. The generic name of Sulfur is niacinamide, adenosine. The product's dosage form is cream and is administered via topical form.

Labeler Name: Selenia

Dosage Form: Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.

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.

Sulfur 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.

  • NIACINAMIDE 1.4 g/70mL
  • ADENOSINE .02 g/70mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • WATER (UNII: 059QF0KO0R)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)

Administration Route(s)

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

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

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

Labeler Name: Selenia
Labeler Code: 71946
Marketing Category: UNAPPROVED DRUG OTHER - 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: 12-01-2017 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’.

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Sulfur Product Label Images

Sulfur 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

Active Ingredient

Active ingredients: Niacinamide 2.0%, Adenosine 0.04%

Inactive Ingredient

Inactive ingredients: Water, Caprylic/Capric Triglyceride , Dimethyl Sulfone, Butylene Glycol, Glycerin, Cyclopentasiloxane, Cyclohexasiloxane, Polysorbate 60, Helianthus Annuus (Sunflower) Seed Oil, Squalane, Isopropyl Myristate, Glyceryl Stearate, PEG-100 Stearate, Betaine, Dimethicone, Stearic Acid, Cetearyl Alcohol, Sorbitan Stearate, Carbomer, Arginine, Butylene Glycol, Panthenol, Tocopheryl Acetate, Biosaccharide Gum-1, Decylene Glycol, Hexylene Glycol, Fragrance, Glyceryl Polyacrylate, 3-O-Ethyl Ascorbic Acid, Hippophae Rhamnoides Fruit Extract, Totarol, Ethylhexylglycerin, Disodium EDTA, Allantoin, Retinyl Palmitate, Phenoxyethanol, Sodium Hyaluronate, Portulaca Oleracea Extract, Camellia Sinensis Leaf Extract, Bambusa Vulgaris Leaf/Stem Extract, Ginkgo Biloba Leaf Extract, Prunus Mume Fruit Extract, Mangifera Indica (Mango) Fruit Extract, Prunus Persica (Peach) Fruit Extract, Fragaria Chiloensis (Strawberry) Fruit Extract, Prunus Serotina (Wild Cherry) Fruit Extract, Centella Asiatica Leaf Extract, Punica Granatum Fruit Extract, Olea Europaea (Olive) Fruit Extract, Chlorella Minutissima Extract, Coptis Chinensis Root Extract, Aspalathus Linearis Extract, Laminaria Japonica Extract, Rubus Fruticosus (Blackberry) Fruit Extract, Cladosiphon Okamuranus Extract , Cordyceps Sinensis Extract, Honey Extract, 1,2-Hexanediol, Aloe Barbadensis Leaf Juice, Morus Alba Bark Extract, Lilium Candidum Flower Extract, Lavandula Angustifolia (Lavender) Flower/Leaf/Stem Extract, Chamomilla Recutita (Matricaria) Flower/Leaf Extract, Rosmarinus Officinalis (Rosemary) Flower/Leaf/Stem Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Nelumbium Speciosum Flower Extract, Saussurea Involucrata Extract, Bellis Perennis (Daisy) Flower Extract, Houttuynia Cordata Extract, Gnaphalium Leontopodium Flower Extract, Panax Ginseng Root Extract, Ocimum Basilicum (Basil) Leaf Extract, Althaea Officinalis Leaf/Root Extract, Houttuynia Cordata Extract, Foeniculum Vulgare (Fennel) Fruit Extract, Artemisia Capillaris Flower Extract, Paeonia Albiflora Root Extract, Angelica Gigas Root Extract, Sophora Angustifolia Root Extract, Leonurus Sibiricus Flower/Leaf/Stem Extract, Ailanthus Altissima Bark Extract, Cnidium Officinale Root Extract, Morus Alba Bark Extract

Purpose

Purpose: Skin Brightening & Anti wrinkle

Warnings

Warnings: For external use only Avoid contact with eyes. Discontinue use if signs of irritation or rashes appear. Replace the cap after use. Keep out of reach of children

Keep Out Of Reach Of Children

KEEP OUT OF REACH OF CHILDREN

Uses

Uses:- Improves elasticity- Nourishing moisturization- Skin softness

Directions

Directions:Massage the cream onto face and neck after cleaning.

* Please review the disclaimer below.