ARCA RegnerationShampoo

Manufacturer
Hair Arca, Inc | Gopher Co., Ltd.
Effective date
2022-10-04
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:51:32

Label at a glance#

ProductARCA RegnerationShampoo
Active ingredientGLYCERIN, MENTHOL, PINUS RADIATA BARK, CITRIC ACID MONOHYDRATE
Label structure11 sections

Indications and 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.

Dosage and administration

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)

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

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

Purpose

OTC - PURPOSE SECTION

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

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

For external use only.

Warnings

OTC - WHEN USING SECTION

When using this product keep out of eyes.
Rinse with water to remove.

Warnings

OTC - STOP USE SECTION

Stop use and ask doctor if conditions worsens or does not improve after regular use of this product as directed.

Warnings

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Warnings

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin.

Directions

DOSAGE & ADMINISTRATION SECTION

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

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

83104-401

ARCA Regeneration Shampoo_LabelARCA Regeneration Shampoo_Label

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ANHYDROUS CITRIC ACID Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813
GLYCERIN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
83104-401-012023-07-28C16284748780-10191ceaa-6bd2-198a-e063-dbdaa90aec3e83104-401 ARCA Regeneration Shampoo

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83104-401-01ARCA RegnerationShampoo503 mL in 1 BOTTLE, PUMPSHAMPOO5031

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83104-401ARCA REGNERATIONSHAMPOO (PINUS RADIATA BARK EXTRACT, GLYCERIN, MENTHOL, CITRIC ACID) SHAMPOO [HAIR ARCA, INC]1Legacy NDC, 1 package rows20221115_ea2f7ec2-f051-074c-e053-2a95a90ade6b.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 35 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83104-40183104-401-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 32 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ea2f7ec2-f052-074c-e053-2a95a90ade6bea2f7ec2-f051-074c-e053-2a95a90ade6b2022-10-04WarningsExact identifier
spl id: ea2f7ec2-f052-074c-e053-2a95a90ade6b
spl set id: ea2f7ec2-f051-074c-e053-2a95a90ade6b

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.