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

ARCA RegnerationShampoo by

Drug Labeling and Warnings

ARCA RegnerationShampoo by is a Otc medication manufactured, distributed, or labeled by Hair Arca, Inc, Gopher Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83104-401
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	2 g  in 100 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.5 g  in 100 mL
PINUS RADIATA BARK (UNII: 6XOU3E49T8) (PINUS RADIATA BARK - UNII:6XOU3E49T8)	PINUS RADIATA BARK	0.05 g  in 100 mL
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL)	ANHYDROUS CITRIC ACID	0.5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83104-401-01	503 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	10/04/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	M032	10/04/2022

Labeler - Hair Arca, Inc (106984414)

Registrant - Hair Arca, Inc (106984414)

Establishment
Name	Address	ID/FEI	Business Operations
Gopher Co., Ltd.		695650633	manufacture(83104-401)