NDC 80592-202 Aqua De Folli Hair Booster

Sr-rainbow Trout Oligopeptide-1 Sh-polypeptide-13, Sr-rainbow Trout Oligopeptide-1 Sh-oligopeptide-2, Sr-rainbow Trout Oligopeptide-1 Sh-polypeptide-1, Sr-rainbow Trout Oligopeptide-1 Sh-polypeptide-8, Sr-rainbow Trout Oligopeptide-1 Sh-polypeptide-9, Magnesium Sulfate, Sodium Bicarbonate, Zinc Sulfate

NDC Product Code 80592-202

NDC CODE: 80592-202

Proprietary Name: Aqua De Folli Hair Booster 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: Sr-rainbow Trout Oligopeptide-1 Sh-polypeptide-13, Sr-rainbow Trout Oligopeptide-1 Sh-oligopeptide-2, Sr-rainbow Trout Oligopeptide-1 Sh-polypeptide-1, Sr-rainbow Trout Oligopeptide-1 Sh-polypeptide-8, Sr-rainbow Trout Oligopeptide-1 Sh-polypeptide-9, Magnesium Sulfate, Sodium Bicarbonate, Zinc Sulfate 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.

  • Drug uses not available
  • Drug uses not available

NDC Code Structure

  • 80592 - Rokit Healthcare Inc.

NDC 80592-202-01

Package Description: 15 mL in 1 BOTTLE

NDC Product Information

Aqua De Folli Hair Booster with NDC 80592-202 is a a human over the counter drug product labeled by Rokit Healthcare Inc.. The generic name of Aqua De Folli Hair Booster is sr-rainbow trout oligopeptide-1 sh-polypeptide-13, sr-rainbow trout oligopeptide-1 sh-oligopeptide-2, sr-rainbow trout oligopeptide-1 sh-polypeptide-1, sr-rainbow trout oligopeptide-1 sh-polypeptide-8, sr-rainbow trout oligopeptide-1 sh-polypeptide-9, magnesium sulfate, sodium bicarbonate, zinc sulfate. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Rokit Healthcare Inc.

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.

Aqua De Folli Hair Booster 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.

  • MAGNESIUM SULFATE, UNSPECIFIED .00024 g/100mL
  • SODIUM BICARBONATE .006 g/100mL
  • ZINC SULFATE .0000022 g/100mL

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.

  • LEUCINE (UNII: GMW67QNF9C)
  • LYSINE HYDROCHLORIDE (UNII: JNJ23Q2COM)
  • METHIONINE (UNII: AE28F7PNPL)
  • SERINE (UNII: 452VLY9402)
  • THREONINE (UNII: 2ZD004190S)
  • TRYPTOPHAN (UNII: 8DUH1N11BX)
  • BIOTIN (UNII: 6SO6U10H04)
  • CALCIUM PANTOTHENATE (UNII: 568ET80C3D)
  • NIACINAMIDE (UNII: 25X51I8RD4)
  • RIBOFLAVIN (UNII: TLM2976OFR)
  • THIAMINE HYDROCHLORIDE (UNII: M572600E5P)
  • COCETH-7 (UNII: 58Y261JLH5)
  • PPG-1-PEG-9 LAURYL GLYCOL ETHER (UNII: 5R8J43K25L)
  • BECAPLERMIN (UNII: 1B56C968OA)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • CALCIUM CHLORIDE (UNII: M4I0D6VV5M)
  • FERRIC SULFATE (UNII: 3HWS7HF5XD)
  • SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
  • THIOCTIC ACID (UNII: 73Y7P0K73Y)
  • SODIUM PYRUVATE (UNII: POD38AIF08)
  • ALANINE (UNII: OF5P57N2ZX)
  • CYSTINE (UNII: 48TCX9A1VT)
  • GLYCINE (UNII: TE7660XO1C)
  • ISOLEUCINE (UNII: 04Y7590D77)
  • PREZATIDE COPPER (UNII: 6BJQ43T1I9)
  • WATER (UNII: 059QF0KO0R)
  • 1,2-HEXANEDIOL (UNII: TR046Y3K1G)
  • FIBROBLAST GROWTH FACTOR 7 (UNII: 9YXF283GP1)
  • ANHYDROUS DEXTROSE (UNII: 5SL0G7R0OK)
  • CUPRIC SULFATE (UNII: LRX7AJ16DT)
  • POTASSIUM CHLORIDE (UNII: 660YQ98I10)
  • MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
  • ASPARTIC ACID (UNII: 30KYC7MIAI)
  • SODIUM PHOSPHATE (UNII: SE337SVY37)
  • PHENYLALANINE (UNII: 47E5O17Y3R)
  • PROLINE (UNII: 9DLQ4CIU6V)
  • HYALURONATE SODIUM (UNII: YSE9PPT4TH)
  • HUMAN TYPE III COLLAGEN (UNII: 5D8UAE62VB)
  • FERRIC NITRATE (UNII: N8H8402XOB)
  • LINOLEIC ACID (UNII: 9KJL21T0QJ)
  • ARGININE HYDROCHLORIDE (UNII: F7LTH1E20Y)
  • ASPARAGINE (UNII: 5Z33R5TKO7)
  • INOSITOL (UNII: 4L6452S749)
  • TYROSINE (UNII: 42HK56048U)
  • VALINE (UNII: HG18B9YRS7)
  • FOLIC ACID (UNII: 935E97BOY8)
  • ADENOSINE (UNII: K72T3FS567)
  • PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)
  • CYANOCOBALAMIN (UNII: P6YC3EG204)
  • POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
  • HISTIDINE MONOHYDROCHLORIDE (UNII: 1D5Q932XM6)
  • CYSTEINE (UNII: K848JZ4886)
  • GLUTAMIC ACID (UNII: 3KX376GY7L)
  • GLUTAMINE (UNII: 0RH81L854J)
  • THYMIDINE (UNII: VC2W18DGKR)

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: Rokit Healthcare Inc.
Labeler Code: 80592
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: 09-24-2020 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: 12-31-2021 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.

Aqua De Folli Hair Booster Product Label Images

Aqua De Folli Hair Booster 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[S]

Sr-Rainbow Trout Oligopeptide-1 sh-Polypeptide-13 (0.0001%)sr-Rainbow Trout Oligopeptide-1 sh-Oligopeptide-2 (0.0001%)sr-Rainbow Trout Oligopeptide-1 sh-Polypeptide-1 (0.0001%)sr-Rainbow Trout Oligopeptide-1 sh-Polypeptide-8 (0.0001%)sr-Rainbow Trout Oligopeptide-1 sh-Polypeptide-9 (0.0001%)Sodium Bicarbonate (0.006%)Zinc Sulfate (0.0000022%)Magnesium Sulfate (0.00024%)

Purpose

Hair growthSkin protectantAcene

Use[S]

To regrow hair on the scalp

Warnings

For external use only.Avoid contact with eyes.In case of contact, flush thoroughly with water.

Stop use and ask a doctor if condition worsens, symptoms last more than 7 days or clear up and occur again within a few days.

Keep out of reach of children. In case of accidental ingestion contact a physician or Poison Control Center right away.

Directions

- Apply 2ml of ampoule directly onto the scalp in the hair loss area- Continued use is necessary to increase and keep your hair regrowth, or hair loss will begin again

Other Information

- Store between 2-25℃ (36-77℉)

- Avoid freezing and excessive heat above 40℃ (104℉)

Inactive Ingredients

1,2-Hexanediol, Niacinamide, Sodium Hyaluronate, Sh-Polypeptide-59, Sh-Polypeptide-3, Sh-Polypeptide-69, Copper Tripeptide-1, Sodium Chloride, Glucose, Calcium Chloride, Copper Sulfate, Ferric Nitrate, Ferric Sulfate, Potassium Chloride, Magnesium Chloride, Sodium Phosphate, Disodium Phosphate, Linoleic Acid, Thioctic Acid, Sodium Pyruvate, Alanine, Arginine Hcl, Asparagine, Aspartic Acid, Cysteine, Cystine, Glutamic Acid, Glutamine, Glycine, Histidine Hcl, Isoleucine, Leucine, Lysine Hcl, Methionine, Phenylalanine, Proline, Serine, Threonine, Tryptophan, Tyrosine, Valine, Thymidine, Biotin, Calcium Pantothenate, Folic Acid, Inositol, Adenosine, Pyridoxine Hcl, Riboflavin, Thiamine Hcl, Cyanocobalamin, Coceth-7, PEG-40 Hydrogenated Castor Oil, PPG-1-PEG-9 Lauryl Glycol Ether

* Please review the disclaimer below.