Label: ARCA REGNERATIONSHAMPOO- pinus radiata bark extract, glycerin, menthol, citric acid shampoo

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated October 4, 2022

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  • Active ingredients

    Pinus Radiata Bark Extract 0.05%
    Glycerin 2%
    Menthol 0.5 %
    Citric Acid 0.5%

  • Purpose

    Pinus Radiata Bark Extract 0.05% - Skin Protectant
    Glycerin 2% - Skin Protectant
    Menthol 0.5 % - Dandruff Control
    Citric Acid 0.5% - pH Level Control



  • Uses

    Helps to keep scalp healthy by controlling follicle and protecting skin.

    If used together with other Arca hair products, helps hair enrichment and decreases the risks of hair loss and various scalp troubles.

  • Warnings

    For external use only.

  • Warnings

    When using this product keep out of eyes.
    Rinse with water to remove.

  • Warnings

    Stop use and ask doctor if conditions worsens or does not improve after regular use of this product as directed.

  • Warnings

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Warnings

    Do not use on damaged or broken skin.

  • Directions

    ARCA REGENRATION SHAMPOO recommends the following instructions for scalp improvement and skin troubles.


    1 Wet your hair and scalp completely with clean warm water before shampoo
    2 Use 1-3 shampoo pumps to massage your scalp and hair.
    Then wait 2 to 3 minutes.
    3 Rinse thoroughly with warm water.
    (Head spa is recommended after hair shampoo use)

  • Inactive ingredients

    Aqua, Coco-glucoside, Lauryl Glucoside, Sodium Cocoyl Isethionate, Coco-Betaine, Polyquaternium-10, Butylene Glycol, Citric Acid, Sodium Chloride, Lavandula Angustifolia (Lavender) Flower Extract, Monarda Didyma Leaf Extract, Mentha Piperita (Peppermint) Leaf Extract, Freesia Refracta Extract, Chamomilla Recutita (Matricaria) Flower Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Pinus Radiata Bark Extract, Panthenol, Sodium Hyaluronate, Polyquaternium-7, coconut fatty acid, Sodium Isethionate, 1,2-Hexandiol 1,2-, Sodium Benzoate, Caprylyl Glycol, Ethylhexylglycerin, Disodium, fragrance, Limonene, Geraniol, Linalool

  • Display Panel

    83104-401

    ARCA Regeneration Shampoo_Label

  • INGREDIENTS AND APPEARANCE
    ARCA REGNERATIONSHAMPOO 
    pinus radiata bark extract, glycerin, menthol, citric acid shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83104-401
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN2 g  in 100 mL
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.5 g  in 100 mL
    PINUS RADIATA BARK (UNII: 6XOU3E49T8) (PINUS RADIATA BARK - UNII:6XOU3E49T8) PINUS RADIATA BARK0.05 g  in 100 mL
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL) ANHYDROUS CITRIC ACID0.5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD) (UNII: 0L414VCS5Y)  
    FRAGRANCE LEMON ORC2001060 (UNII: K1725A7G95)  
    FREESIA ALBA FLOWER (UNII: 33X293N6JT)  
    MONARDA DIDYMA LEAF (UNII: JY15982UBB)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    CHAMOMILE (UNII: FGL3685T2X)  
    SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493)  
    POLYQUATERNIUM-10 (400 CPS AT 2%) (UNII: HB1401PQFS)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)  
    COCO GLUCOSIDE (UNII: ICS790225B)  
    COCO-BETAINE (UNII: 03DH2IZ3FY)  
    LAVANDULA ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)  
    SODIUM ISETHIONATE (UNII: 3R36J71C17)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    COCONUT ACID (UNII: 40U37V505D)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    GERANIOL (UNII: L837108USY)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    WATER (UNII: 059QF0KO0R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    ROSEMARY (UNII: IJ67X351P9)  
    MENTHA PIPERITA LEAF (UNII: A389O33LX6)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83104-401-01503 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product10/04/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM03210/04/2022
    Labeler - Hair Arca, Inc (106984414)
    Registrant - Hair Arca, Inc (106984414)
    Establishment
    NameAddressID/FEIBusiness Operations
    Gopher Co., Ltd.695650633manufacture(83104-401)
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