ARCA Regeneration Head Spa

Manufacturer
Hair Arca, Inc | Gopher Co., Ltd.
Effective date
2022-09-29
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:51:32

Label at a glance#

ProductARCA Regeneration Head Spa
Active ingredientSALICYLIC ACID
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 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.

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Pinus Radiata Bark Extract 0.05%

Menthol 0.5%

Salicylic Acid 0.5%

Purpose

OTC - PURPOSE SECTION

Pinus Radiata Bark Extract 0.05% - Skin Protectant

Menthol 0.5% - Dandruff Control

Salicylic Acid 0.5% - Dandruff 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 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

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

83104-401

ARCA Regeneration Head Spa_LabelARCA Regeneration Head Spa_Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
83104-301-012023-07-28C16284748780-10191ceaa-6df2-198a-e063-dbdaa90aec3e83104-301 ARCA Regeneration Head Spa

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83104-301-01ARCA Regeneration Head Spa503 mL in 1 BOTTLE, PUMPSHAMPOO5031

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83104-301ARCA REGENERATION HEAD SPA (PINUS RADIATA BARK EXTRACT, MENTHOL, SALICYLIC ACID) SHAMPOO [HAIR ARCA, INC]1Legacy NDC, 1 package rows20221115_e9dce5c6-9b6d-adc4-e053-2a95a90a0378.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
83104-30183104-301-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 33 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
e9dce5c6-9b6e-adc4-e053-2a95a90a0378e9dce5c6-9b6d-adc4-e053-2a95a90a03782022-09-29WarningsExact identifier
spl id: e9dce5c6-9b6e-adc4-e053-2a95a90a0378
spl set id: e9dce5c6-9b6d-adc4-e053-2a95a90a0378

Reported adverse events (FAERS/openFDA)#

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