FDA.reportPublic FDA data

ROOTSALLO ADVANCED SCALP CARE HAIR

Manufacturer
rootsallo Qwell | DONGBANG COSMETIC CO.,LTD.
Effective date
2021-12-30
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:46:09

Label at a glance#

ProductROOTSALLO ADVANCED SCALP CARE HAIR
Active ingredientSalicylic Acid, Menthol, Panthenol
Label structure10 sections

Indications and uses

Certified shampoo for hair loss Helps improve scalp care and gives the conditioning effect.

Dosage and administration

Wet hair and take an appropriate amount of shampoo and mix it into your hands. Massage throughout wet hair and scalp for 1~3 minutes gently and rinse thoroughly.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Salicylic Acid 0.25%
Menthol 0.3%
Panthenol 0.2%

PURPOSE

OTC - PURPOSE SECTION

Deep Cleansing, Refreshing Scalp, Anti Hair-Loss

Uses

INDICATIONS & USAGE SECTION

Certified shampoo for hair loss
Helps improve scalp care and gives the conditioning effect.

Warnings

WARNINGS SECTION

For external use only.
In case of having side effects such as red rash, swollenness and/or itching while using this cosmetic consult a dermatologist immediately.
Keep out of reach of children.

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN

Directions

DOSAGE & ADMINISTRATION SECTION

Wet hair and take an appropriate amount of shampoo and mix it into your hands. Massage throughout wet hair and scalp for 1~3 minutes gently and rinse thoroughly.

Other Information

OTHER SAFETY INFORMATION

Do not store this product in an inappropriate place such as high or low temperatures or under direct sun light.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Lauryl Glucoside, Butylene Glycol, Sodium methyl cocoyl taurate, Sodium cocoyl alaninate, Chamaecyparis Obtusa Oil, 1,2-Hexanediol, Dipropylene Glycol, Sodium chloride, Citric Acid, Polyquaternium-10, Polianthes tuberosa extract, Ethylhexylglycerin, Silicone Quaternium-22, Hydroxyethyl Urea, Disodium EDTA, Hydrolyzed Wheat Protein, Hydrolyzed Keratin, Polyglyceryl-3 Caprate, Rehmannia Chinensis Root Extract, Cornus Officinalis Fruit Extract, Dioscorea Japonica Root Extract, Alisma Orientale Tuber Extract, Poria Cocos Sclerotium Extract, Paeonia Suffruticosa Root Extract, Avena Sativa (Oat) Protein Extract, Gaultheria Procumbens (Wintergreen) Leaf Extract, Sambucus Nigra Flower Extract, Malva Sylvestris (Mallow) Extract, Melissa Officinalis Leaf Extract, Mentha Piperita (Peppermint) Leaf Extract, Achillea Millefolium Extract, Eucalyptus Globulus Leaf Extract, Cryptomeria Japonica Leaf Extract, Hyssopus Officinalis Extract, Saccharomyces Cerevisiae Extract, Sodium Benzoate, Phenoxyethanol, Methylparaben, Propylparaben

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of cartonImage of carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2100019menthol 0.3 % / panthenol 0.2 % / salicylic acid 0.25 % Medicated ShampooPSN1
2100019menthol 3 MG/ML / panthenol 2 MG/ML / salicylic acid 2.5 MG/ML Medicated ShampooSCD1
2100019menthol 0.3 % / panthenol 0.2 % / salicylic acid 0.25 % Medicated ShampooSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
82450-040-022023-01-30C16284748780-1f386c649-a37a-0266-e053-dadaa90a7c1ae1e9d71c-5a07-4fa9-bbfa-ef75133ce404

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82450-040-01ROOTSALLO ADVANCED SCALP CARE HAIR350 mL in 1 CONTAINERSHAMPOO3501
82450-040-02ROOTSALLO ADVANCED SCALP CARE HAIR1 in 1 CARTONSHAMPOO11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82450-040ROOTSALLO ADVANCED SCALP CARE HAIR (SALICYLIC ACID, MENTHOL, PANTHENOL) SHAMPOO [ROOTSALLO QWELL]1Legacy NDC, 2 package rows20211231_e1e9d71c-5a07-4fa9-bbfa-ef75133ce404.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82450-04082450-040-01, 82450-040-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
Salicylic AcidO414PZ4LPZACTIB
MentholL7T10EIP3AACTIB
PanthenolWV9CM0O67ZACTIB
Water059QF0KO0RIACT
Lauryl Glucoside76LN7P7UCUIACT
Butylene Glycol3XUS85K0RAIACT

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
741e15e6-f0ff-4880-86d7-61047c10c06ee1e9d71c-5a07-4fa9-bbfa-ef75133ce4042021-12-30WarningsExact identifier
spl id: 741e15e6-f0ff-4880-86d7-61047c10c06e
spl set id: e1e9d71c-5a07-4fa9-bbfa-ef75133ce404

Reported adverse events (FAERS/openFDA)#

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