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 liquid 
ROKIT HEALTHCARE Inc.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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80592-202

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 growth

Skin protectant

Acene

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.

Warnings

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.

Warnings

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

Package Label

15ml NDC: 80592-202-01 Label

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 liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80592-202
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB) (SULFATE ION - UNII:7IS9N8KPMG) MAGNESIUM SULFATE, UNSPECIFIED0.00024 g  in 100 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) (BICARBONATE ION - UNII:HN1ZRA3Q20) SODIUM BICARBONATE0.006 g  in 100 mL
ZINC SULFATE (UNII: 89DS0H96TB) (ZINC CATION - UNII:13S1S8SF37) ZINC SULFATE0.0000022 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80592-202-0115 mL in 1 BOTTLE; Type 0: Not a Combination Product09/24/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other09/24/2020
Labeler - ROKIT HEALTHCARE Inc. (689004656)
Registrant - ROKIT HEALTHCARE Inc. (689004656)
Establishment
NameAddressID/FEIBusiness Operations
ROKIT HEALTHCARE Inc.689004656label(80592-202)
Establishment
NameAddressID/FEIBusiness Operations
BIO-FD&C CO., LTD694287377manufacture(80592-202)

Revised: 10/2020
Document Id: b0f79a41-6b38-8806-e053-2995a90a7dc2
Set id: afe30bac-a8cb-4f9a-e053-2995a90ab4ce
Version: 2
Effective Time: 20201005
 
ROKIT HEALTHCARE Inc.