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

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

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Drug Label Information

Updated October 5, 2020

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  • 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 2ml of ampoule 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

    1,2-Hexanediol, 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

    15ml NDC: 80592-202-01 Label

  • INGREDIENTS AND APPEARANCE
    AQUA DE FOLLI HAIR BOOSTER 
    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, magnesium sulfate, sodium bicarbonate, zinc sulfate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80592-202
    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
    LEUCINE (UNII: GMW67QNF9C)  
    LYSINE HYDROCHLORIDE (UNII: JNJ23Q2COM)  
    METHIONINE (UNII: AE28F7PNPL)  
    SERINE (UNII: 452VLY9402)  
    THREONINE (UNII: 2ZD004190S)  
    TRYPTOPHAN (UNII: 8DUH1N11BX)  
    BIOTIN (UNII: 6SO6U10H04)  
    CALCIUM PANTOTHENATE (UNII: 568ET80C3D)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    RIBOFLAVIN (UNII: TLM2976OFR)  
    THIAMINE HYDROCHLORIDE (UNII: M572600E5P)  
    COCETH-7 (UNII: 58Y261JLH5)  
    PPG-1-PEG-9 LAURYL GLYCOL ETHER (UNII: 5R8J43K25L)  
    BECAPLERMIN (UNII: 1B56C968OA)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    CALCIUM CHLORIDE (UNII: M4I0D6VV5M)  
    FERRIC SULFATE (UNII: 3HWS7HF5XD)  
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
    THIOCTIC ACID (UNII: 73Y7P0K73Y)  
    SODIUM PYRUVATE (UNII: POD38AIF08)  
    ALANINE (UNII: OF5P57N2ZX)  
    CYSTINE (UNII: 48TCX9A1VT)  
    GLYCINE (UNII: TE7660XO1C)  
    ISOLEUCINE (UNII: 04Y7590D77)  
    PREZATIDE COPPER (UNII: 6BJQ43T1I9)  
    WATER (UNII: 059QF0KO0R)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    FIBROBLAST GROWTH FACTOR 7 (UNII: 9YXF283GP1)  
    ANHYDROUS DEXTROSE (UNII: 5SL0G7R0OK)  
    CUPRIC SULFATE (UNII: LRX7AJ16DT)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    ASPARTIC ACID (UNII: 30KYC7MIAI)  
    SODIUM PHOSPHATE (UNII: SE337SVY37)  
    PHENYLALANINE (UNII: 47E5O17Y3R)  
    PROLINE (UNII: 9DLQ4CIU6V)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    HUMAN TYPE III COLLAGEN (UNII: 5D8UAE62VB)  
    FERRIC NITRATE (UNII: N8H8402XOB)  
    LINOLEIC ACID (UNII: 9KJL21T0QJ)  
    ARGININE HYDROCHLORIDE (UNII: F7LTH1E20Y)  
    ASPARAGINE (UNII: 5Z33R5TKO7)  
    INOSITOL (UNII: 4L6452S749)  
    TYROSINE (UNII: 42HK56048U)  
    VALINE (UNII: HG18B9YRS7)  
    FOLIC ACID (UNII: 935E97BOY8)  
    ADENOSINE (UNII: K72T3FS567)  
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)  
    CYANOCOBALAMIN (UNII: P6YC3EG204)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    HISTIDINE MONOHYDROCHLORIDE (UNII: 1D5Q932XM6)  
    CYSTEINE (UNII: K848JZ4886)  
    GLUTAMIC ACID (UNII: 3KX376GY7L)  
    GLUTAMINE (UNII: 0RH81L854J)  
    THYMIDINE (UNII: VC2W18DGKR)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80592-202-0115 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(80592-202)
    Establishment
    NameAddressID/FEIBusiness Operations
    BIO-FD&C CO., LTD694287377manufacture(80592-202)
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