FDA.reportPublic FDA data

AQUA DE FOLLI HAIR BOOSTER MINI

Manufacturer
ROKIT HEALTHCARE Inc. | BIO-FD&C CO., LTD
Effective date
2020-10-05
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:31:03

Label at a glance#

ProductAQUA DE FOLLI HAIR BOOSTER MINI
Active ingredientZINC SULFATE, SODIUM BICARBONATE, MAGNESIUM SULFATE, UNSPECIFIED
Label structure10 sections

Dosage and administration

- 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

Storage and handling

- Store between 2-25℃ (36-77℉) - Avoid freezing and excessive heat above 40℃ (104℉)

Label contents#

Full prescribing information#

Active ingredient[s]

OTC - ACTIVE INGREDIENT SECTION

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

OTC - PURPOSE SECTION

Hair growth

Skin protectant

Acene

Use[s]

DOSAGE & ADMINISTRATION SECTION

To regrow hair on the scalp

Warnings

WARNINGS SECTION

For external use only.

Avoid contact with eyes.

In case of contact, flush thoroughly with water.

Warnings

OTC - ASK DOCTOR SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

INDICATIONS & USAGE SECTION

- 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

STORAGE AND HANDLING SECTION

- Store between 2-25℃ (36-77℉)
- Avoid freezing and excessive heat above 40℃ (104℉)

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

5ml NDC: 80592-203-01 Label5ml NDC: 80592-203-01 Label

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
BICARBONATE ION Pharmacologic Class Indexing1Indexing - Pharmacologic Class20220121
SULFATE ION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
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5e18e798-5614-cf5c-0185-38b1cb77a093Product name220160822
d41954ff-bc63-4b2c-aba0-9146707659d7Product name220151117
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
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FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80592-203-012022-01-28C16284748780-1d6a99b39-6265-a426-e053-dadaa90af4c280592-203

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80592-203-01AQUA DE FOLLI HAIR BOOSTER MINI5 mL in 1 BOTTLELIQUID52

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80592-203AQUA 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 [ROKIT HEALTHCARE INC.]2Legacy NDC, 1 package rows20201006_aff6006a-6b46-fa2d-e053-2995a90a7fec.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 2 · 63 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80592-20380592-203-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 2 · 58 matching rows.

Name, UNII, Kind table
NameUNIIKind
ADENOSINEK72T3FS567IACT
PYRIDOXINE HYDROCHLORIDE68Y4CF58BVIACT
RIBOFLAVINTLM2976OFRIACT
CYANOCOBALAMINP6YC3EG204IACT
COCETH-758Y261JLH5IACT
GLYCINETE7660XO1CIACT
WATER059QF0KO0RIACT
ISOLEUCINE04Y7590D77IACT
INOSITOL4L6452S749IACT
ZINC SULFATE89DS0H96TBACTIB
SODIUM BICARBONATE8MDF5V39QOACTIB
SODIUM PHOSPHATESE337SVY37IACT
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FIACT
HISTIDINE MONOHYDROCHLORIDE1D5Q932XM6IACT
LEUCINEGMW67QNF9CIACT
THREONINE2ZD004190SIACT
TRYPTOPHAN8DUH1N11BXIACT
TYROSINE42HK56048UIACT
THYMIDINEVC2W18DGKRIACT
FOLIC ACID935E97BOY8IACT
THIAMINE HYDROCHLORIDEM572600E5PIACT
POLYOXYL 40 HYDROGENATED CASTOR OIL7YC686GQ8FIACT
PPG-1-PEG-9 LAURYL GLYCOL ETHER5R8J43K25LIACT
METHIONINEAE28F7PNPLIACT
ASPARAGINE5Z33R5TKO7IACT
GLUTAMIC ACID3KX376GY7LIACT
LYSINE HYDROCHLORIDEJNJ23Q2COMIACT
PHENYLALANINE47E5O17Y3RIACT
PROLINE9DLQ4CIU6VIACT
SERINE452VLY9402IACT
VALINEHG18B9YRS7IACT
BIOTIN6SO6U10H04IACT
CALCIUM PANTOTHENATE568ET80C3DIACT
FIBROBLAST GROWTH FACTOR 79YXF283GP1IACT
ALANINEOF5P57N2ZXIACT
1,2-HEXANEDIOLTR046Y3K1GIACT
NIACINAMIDE25X51I8RD4IACT
HYALURONATE SODIUMYSE9PPT4THIACT
BECAPLERMIN1B56C968OAIACT
PREZATIDE COPPER6BJQ43T1I9IACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
b0f7d476-e327-52fa-e053-2995a90ac429aff6006a-6b46-fa2d-e053-2995a90a7fec2020-10-05WarningsExact identifier
spl id: b0f7d476-e327-52fa-e053-2995a90ac429
spl set id: aff6006a-6b46-fa2d-e053-2995a90a7fec