ARCA REGNERATIONSHAMPOO- pinus radiata bark extract, glycerin, menthol, citric 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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83104-401 ARCA Regeneration Shampoo

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

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)

Revised: 10/2022
Document Id: ea2f7ec2-f052-074c-e053-2a95a90ade6b
Set id: ea2f7ec2-f051-074c-e053-2a95a90ade6b
Version: 1
Effective Time: 20221004
 
Hair Arca, Inc