ARCA TRINITYSHAMPOO- pinus radiata bark extract, glycerin, 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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83104-501 ARCA Trinity Shampoo

Active ingredients

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

Purposes

Pinus Radiata Bark Extract 0.05% - Skin Protectant
Glycerin 2% - Skin Protectant
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 TRINITY 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.
(If the product is used for body shampoo or facial wash, massage the particular area and wait 2-3 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, 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

Display Panel

83104-501

ARCA Trinity Shampoo label

ARCA TRINITYSHAMPOO 
pinus radiata bark extract, glycerin, citric acid shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83104-501
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PINUS RADIATA BARK (UNII: 6XOU3E49T8) (PINUS RADIATA BARK - UNII:6XOU3E49T8) PINUS RADIATA BARK0.05 g  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN2 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
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
CHAMOMILE (UNII: FGL3685T2X)  
HYALURONIC ACID (UNII: S270N0TRQY)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
WATER (UNII: 059QF0KO0R)  
SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493)  
MONARDA DIDYMA LEAF (UNII: JY15982UBB)  
COCO-BETAINE (UNII: 03DH2IZ3FY)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
MENTHA PIPERITA LEAF (UNII: A389O33LX6)  
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD) (UNII: 0L414VCS5Y)  
SODIUM (UNII: 9NEZ333N27)  
LAVANDULA ANGUSTIFOLIA FLOWERING TOP (UNII: 9YT4B71U8P)  
FREESIA ALBA FLOWER (UNII: 33X293N6JT)  
PANTHENOL (UNII: WV9CM0O67Z)  
COCONUT ACID (UNII: 40U37V505D)  
ROSEMARY (UNII: IJ67X351P9)  
LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)  
POLYQUATERNIUM-10 (400 CPS AT 2%) (UNII: HB1401PQFS)  
COCO GLUCOSIDE (UNII: ICS790225B)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83104-501-01503 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(83104-501)

Revised: 10/2022
Document Id: ea2f91b5-b3be-c09a-e053-2995a90a93b9
Set id: ea2f91b5-b3bd-c09a-e053-2995a90a93b9
Version: 1
Effective Time: 20221004
 
Hair Arca, Inc