Label: 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

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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.

Drug Label Information

Updated October 5, 2020

If you are a consumer or patient please visit this version.

  • 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

    3ml NDC: 80592-201-01 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 TypeHUMAN OTC DRUGItem Code (Source)NDC:80592-201
    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
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80592-201-013 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(80592-201)
    Establishment
    NameAddressID/FEIBusiness Operations
    BIO-FD&C CO., LTD694287377manufacture(80592-201)