Label: ARCA REGENERATION HEAD SPA- pinus radiata bark extract, menthol, salicylic 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 September 29, 2022

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  • Active ingredients

    Pinus Radiata Bark Extract 0.05%

    Menthol 0.5%

    Salicylic Acid 0.5%

  • Purpose

    Pinus Radiata Bark Extract 0.05% - Skin Protectant

    Menthol 0.5% - Dandruff Control

    Salicylic Acid 0.5% - Dandruff 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 REGENERATION HEAD SPA recommends the following instructions for scalp improvement and skin troubles.

    (Head Spa is recommended to use 2~3 times a week)

    1 SHAMPOO your hair with ARCA SHAMPOO before using the head spa

    2 Use 1-3 pumps to massage your scalp and hair. Then wait 2 to 3 minutes.

    3 Rinse thoroughly with warm water.

  • Inactive Ingredients

    Aqua, Cetyl Alcohol, Hydroxyethylcellulose, Quaternium-87, Stearamidopropyl Dimethylamine, Cetrimonium Chloride, Steartrimonium Chloride, PPG-3 Caprylyl Ether, Hydroxyethylcellulose, Ricinus Communis(Castor) Seed Oil, Camellia Japonica Seed Oil, Helianthus Annuus (Sunflower) Seed Oil, Behentrimonium Methosulfate, Stearyl Alcohol, Propylene Glycol, Panthenol, Butylene Glycol, 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, Avena Sativa

    (Oat) Kernel Extract, Gelatin, Hydrolyzed Keratin, Hydrolyzed Collagen, Hydrolyzed Corn Protein, Hydrolyzed Soy Protein, Hydrolyzed Wheat Protein, Sodium Benzoate, Citric acid, 1,2-Hexanediol, Caprylyl Glycol, Ethylhexylglycerin, Allantoin, Disodium EDTA,

    fragrance, Limonene

  • Display panel

    83104-401

    ARCA Regeneration Head Spa_Label

  • INGREDIENTS AND APPEARANCE
    ARCA REGENERATION HEAD SPA 
    pinus radiata bark extract, menthol, salicylic acid shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83104-301
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID0.5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    MONARDA DIDYMA LEAF (UNII: JY15982UBB)  
    MENTHA PIPERITA LEAF (UNII: A389O33LX6)  
    CHAMOMILE (UNII: FGL3685T2X)  
    ROSEMARY (UNII: IJ67X351P9)  
    FREESIA ALBA WHOLE (UNII: SS55L6C3QQ)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    OAT (UNII: Z6J799EAJK)  
    PPG-10 CAPRYLYL ETHER (UNII: B1ML6JO7Z2)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    BEHENTRIMONIUM METHOSULFATE (UNII: 5SHP745C61)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
    GELATIN (UNII: 2G86QN327L)  
    HYDROLYZED WHEAT PROTEIN (ENZYMATIC, 3000 MW) (UNII: J2S07SB0YL)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    CAMELLIA JAPONICA SEED OIL (UNII: U37N0S910T)  
    HYDROLYZED SOY PROTEIN (ENZYMATIC; 2000 MW) (UNII: 1394NXB9L6)  
    CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)  
    WATER (UNII: 059QF0KO0R)  
    TRIMETHYL OCTADECYL AMMONIUM CHLORIDE (UNII: CZ70647U92)  
    LAVANDULA ANGUSTIFOLIA SUBSP. ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    STEARAMIDOPROPYL DIMETHYLAMINE (UNII: K7VEI00UFR)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    ALLANTOIN (UNII: 344S277G0Z)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83104-301-01503 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product10/03/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM03210/03/2022
    Labeler - Hair Arca, Inc (106984414)
    Registrant - Hair Arca, Inc (106984414)
    Establishment
    NameAddressID/FEIBusiness Operations
    Gopher Co., Ltd.695650633manufacture(83104-301)
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