AQUA DE FOLLI HAIR BOOSTER MINI: Package Insert and Label Information

AQUA DE FOLLI HAIR BOOSTER MINI- zinc sulfate, sodium bicarbonate and magnesium sulfate, unspecified 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.

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

5ml NDC: 80592-203-01 Label
(click image for full-size original)

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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZINC SULFATE (ZINC CATION) ZINC SULFATE 0.0000022 g in 100 mL
SODIUM BICARBONATE (BICARBONATE ION) SODIUM BICARBONATE 0.006 g in 100 mL
MAGNESIUM SULFATE, UNSPECIFIED (SULFATE ION) MAGNESIUM SULFATE, UNSPECIFIED 0.00024 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
ADENOSINE
PYRIDOXINE HYDROCHLORIDE
RIBOFLAVIN
CYANOCOBALAMIN
COCETH-7
GLYCINE
WATER
ISOLEUCINE
INOSITOL
SODIUM PHOSPHATE
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS
HISTIDINE MONOHYDROCHLORIDE
LEUCINE
THREONINE
TRYPTOPHAN
TYROSINE
THYMIDINE
FOLIC ACID
THIAMINE HYDROCHLORIDE
POLYOXYL 40 HYDROGENATED CASTOR OIL
PPG-1-PEG-9 LAURYL GLYCOL ETHER
METHIONINE
ASPARAGINE
GLUTAMIC ACID
LYSINE HYDROCHLORIDE
PHENYLALANINE
PROLINE
SERINE
VALINE
BIOTIN
CALCIUM PANTOTHENATE
FIBROBLAST GROWTH FACTOR 7
ALANINE
1,2-HEXANEDIOL
NIACINAMIDE
HYALURONATE SODIUM
BECAPLERMIN
PREZATIDE COPPER
SODIUM CHLORIDE
ANHYDROUS DEXTROSE
FERRIC SULFATE
MAGNESIUM CHLORIDE
ARGININE HYDROCHLORIDE
LINOLEIC ACID
THIOCTIC ACID
SODIUM PYRUVATE
ASPARTIC ACID
CYSTEINE
CYSTINE
GLUTAMINE
FERRIC NITRATE
HUMAN TYPE III COLLAGEN
CALCIUM CHLORIDE
CUPRIC SULFATE
POTASSIUM CHLORIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:80592-203-01 5 mL in 1 BOTTLE None
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 Operations
ROKIT HEALTHCARE Inc. 689004656 label (80592-203)
Establishment
Name Address ID/FEI Operations
BIO-FD&C CO., LTD 694287377 manufacture (80592-203)

Revised: 10/2020 ROKIT HEALTHCARE Inc.

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