AQUA DE FOLLI HAIR BOOSTER PRO- 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, sodium bicarbonate, zinc sulfate, magnesium sulfate liquid

AQUA DE FOLLI HAIR BOOSTER PRO by

Drug Labeling and Warnings

AQUA DE FOLLI HAIR BOOSTER PRO by is a Otc medication manufactured, distributed, or labeled by ROKIT HEALTHCARE Inc., BIO-FD&C CO., LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 1 vial once a week 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

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

Package Label

INGREDIENTS AND APPEARANCE

AQUA DE FOLLI HAIR BOOSTER PRO 
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, sodium bicarbonate, zinc sulfate, magnesium sulfate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80592-201
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB) (SULFATE ION - UNII:7IS9N8KPMG)	MAGNESIUM SULFATE, UNSPECIFIED	0.00024 g  in 100 mL
SODIUM BICARBONATE (UNII: 8MDF5V39QO) (BICARBONATE ION - UNII:HN1ZRA3Q20)	SODIUM BICARBONATE	0.006 g  in 100 mL
ZINC SULFATE (UNII: 89DS0H96TB) (ZINC CATION - UNII:13S1S8SF37)	ZINC SULFATE	0.0000022 g  in 100 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80592-201-01	3 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/24/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		09/24/2020

Labeler - ROKIT HEALTHCARE Inc. (689004656)

Registrant - ROKIT HEALTHCARE Inc. (689004656)

Establishment
Name	Address	ID/FEI	Business Operations
ROKIT HEALTHCARE Inc.		689004656	label(80592-201)

Establishment
Name	Address	ID/FEI	Business Operations
BIO-FD&C CO., LTD		694287377	manufacture(80592-201)