ARCA REGENERATION HEAD SPA- pinus radiata bark extract, menthol, salicylic acid shampoo 
Hair Arca, Inc

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.

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83104-301 ARCA Regeneration Head Spa

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

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)

Revised: 9/2022
Document Id: e9dce5c6-9b6e-adc4-e053-2a95a90a0378
Set id: e9dce5c6-9b6d-adc4-e053-2a95a90a0378
Version: 1
Effective Time: 20220929
 
Hair Arca, Inc