AQUA DE FOLLI HAIR BOOSTER MINI- 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 MINI by

Drug Labeling and Warnings

AQUA DE FOLLI HAIR BOOSTER MINI 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 from time to time 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, Coceth-7, PEG-40 Hydrogenated Castor Oil, PPG-1-PEG-9 Lauryl Glycol Ether

Package Label

INGREDIENTS AND APPEARANCE

AQUA DE FOLLI HAIR BOOSTER MINI 
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: 80592-203
Route of Administration	TOPICAL

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

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80592-203-01	5 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(80592-203)

Establishment
Name	Address	ID/FEI	Business Operations
BIO-FD&C CO., LTD		694287377	manufacture(80592-203)