NDC 81457-123 Alevai Stem Cell Anti-dandruff Conditioner

Pyrithione Zinc

NDC Product Code 81457-123

NDC 81457-123-00

Package Description: 236 mL in 1 CYLINDER

NDC Product Information

Alevai Stem Cell Anti-dandruff Conditioner with NDC 81457-123 is a a human over the counter drug product labeled by Alevai Products Llc. The generic name of Alevai Stem Cell Anti-dandruff Conditioner is pyrithione zinc. The product's dosage form is solution and is administered via topical form.

Labeler Name: Alevai Products Llc

Dosage Form: Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.

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.

Alevai Stem Cell Anti-dandruff Conditioner 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.

  • PYRITHIONE ZINC 20 mg/mL

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)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • BEHENTRIMONIUM METHOSULFATE (UNII: 5SHP745C61)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • CORN (UNII: 0N8672707O)
  • COCONUT OIL (UNII: Q9L0O73W7L)
  • CETEARYL OLIVATE (UNII: 58B69Q84JO)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • PPG-26-BUTETH-26 (UNII: 2II1K6TZ4P)
  • POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
  • APIGENIN (UNII: 7V515PI7F6)
  • OLEANOLIC ACID (UNII: 6SMK8R7TGJ)
  • BIOTINOYL TRIPEPTIDE-1 (UNII: O6380721VA)
  • ARGAN OIL (UNII: 4V59G5UW9X)
  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
  • ALMOND (UNII: 3Z252A2K9G)
  • SHEA BUTTER (UNII: K49155WL9Y)
  • SAW PALMETTO (UNII: J7WWH9M8QS)
  • PANTHENOL (UNII: WV9CM0O67Z)
  • BIOTIN (UNII: 6SO6U10H04)
  • AMINO ACIDS, SILK (UNII: V0L00EX1IA)
  • APPLE (UNII: B423VGH5S9)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • PROLINE (UNII: 9DLQ4CIU6V)
  • ARTHROSPIRA PLATENSIS (UNII: 9L3TIH1UUE)
  • CRITHMUM MARITIMUM WHOLE (UNII: J7IHY79BKY)
  • LEONTOPODIUM NIVALE SUBSP. ALPINUM ROOT (UNII: SDW6SS1K6I)
  • LEUCINE (UNII: GMW67QNF9C)
  • VALINE (UNII: HG18B9YRS7)
  • THREONINE (UNII: 2ZD004190S)
  • GREEN TEA LEAF (UNII: W2ZU1RY8B0)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

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.

Product Labeler Information

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

Labeler Name: Alevai Products Llc
Labeler Code: 81457
FDA Application Number: part358H What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. 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: 02-01-2021 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: 12-31-2022 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.

Alevai Stem Cell Anti-dandruff Conditioner Product Label Images

Alevai Stem Cell Anti-dandruff Conditioner 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 Ingredients

Pyrithione Zinc 2%

Purpose

Anti-dandruff

Uses:

  • Helps eliminate reoccurrence of sclap itching, irritation, redness, and falking associated with dandruff.

Warnings:

For external use only

When Using This Product

  • Avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water.

Stop Use And Ask A Doctor If

  • Condition worsens or does not improve after regular use of this product as directed.

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions:

  • For best results use at least twice a week or as directed by a doctor.Apply to wet hair after shampooing by gently massaging into hair and scalp, rinse well.

Other Information:

  • Protect the product in this container from excessive heat and direct sun.

Inactive Ingredients:

Aqua (Deionized Water), Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Behentrimonium Methosulfate, Cetearyl Alcohol, Glycerin, Zemea (Corn) Propanediol, Cocous Nucifera (Coconut) Oil, Cetearyl Olivate, Butylene Glycol, PPG-26-Buteth-26, PEG-40 Hydrogenated Castor Oil, Apigenin, Oleanolic Acid, Biotonyl Tripeptide-1, Argania Spinosa (Argan) Oil, Caprylic/Capric Triglyceride, Hydrolyzed Keratin Protein, Prunus Amygdalus Dulcis (Almond) Oil,Butyropermum Pakii (Shea) Butter, Serenoa Serrulata (Saw Palmetto) Extract, dl-Panthenol, Biotin, Silk Amino Acids, Malus Domestica (Apple) Fruit Cell Culture Extract, Buddleja Davidii Meristem Cell Culture, Xanthan Gum, I-Proline, Spirulina Platensis (Spirulina) Extract, Lamanaria Digitata (Sea Kelp) Extract, Crithmum Maritimum (Sea Fennel) Extract, Leontopodium Alpinum (Edelweiss) Stem Extarct, L-Leucine, L-Valine, Guar Hydroxypopyltrimonium Chloride, L-Threonine, Camellia Sinesis (Green Tea) Extract, Parfum (Fragrance), Phenoxyethanol, Ethylhexylglycerin.

* Please review the disclaimer below.