FDA.reportPublic FDA data

ROOTSALLO TOOTHPASTE

Manufacturer
rootsallo Qwell | Woorilife&Health
Effective date
2021-12-30
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:46:16

Label at a glance#

ProductROOTSALLO TOOTHPASTE
Active ingredientCALCIUM CARBONATE, ALCLOXA, Aminocaproic Acid, DIBASIC CALCIUM PHOSPHATE DIHYDRATE
Label structure10 sections

Indications and uses

Antiplaque, Anticavity, Healthy Gums Toothpaste

Dosage and administration

Brushing the teeth with a suitable amount

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

CALCIUM CARBONATE 10.30%
ALCLOXA 0.05%
Aminocaproic Acid 0.05%
DIBASIC CALCIUM PHOSPHATE DIHYDRATE 0.30%

PURPOSE

OTC - PURPOSE SECTION

Anti plaque, Anti cavities, Healthy Gums, Prevent Gingivitis and Perioodontitis,  Prevent Periodontal Disease

Uses

INDICATIONS & USAGE SECTION

Antiplaque, Anticavity, Healthy Gums Toothpaste

Warnings

WARNINGS SECTION

(1) Do not swallow, gargle fully after using.
(2) If the use of this paste causes gingiva or oral cavity injury, please stop using and consult a doctor or a dentist.
(3) If childern under 6 years of age use, please apply a pea-sized amount each thime.
Do not swallow. Please use under the guidance of the guardian.
(4) If children under 6 years of age accidentally ingest large amounts of the paste, please consult a doctor or a dentist immediately.
(5) Keep out of reach of children under 6 years of age.
(6) This product contains sodium benzoate, which has mild irritation to the skin, eyes and mucosa.

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children under 6 years of age.

Directions

DOSAGE & ADMINISTRATION SECTION

Brushing the teeth with a suitable amount

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

D-Sorbitol Solution, Glycerin, Silica, Xanthan Gum, Carboxymethylcellulose Sodium, Sodium Lauryl Sulfate, Grapefruit Seed Extract, Saccharin Sodium Hydrate, Xylitol, L-Menthol, Green Tea Extract, Propolis Extract, Chitosan, Phytoncide Flavor, Chamaecyparis Obtusa Oil, Water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of cartonImage of carton

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
AMINOCAPROIC ACID Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
CALCIUM CATION Pharmacologic Class Indexing3Indexing - Pharmacologic Class20230427

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bee4fa8d-8d82-423a-a0b5-40a89dd13a99Product name120250618
e0d2eb29-08bd-4bba-90d1-c91c68a38767Product name420250516
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
83904ae6-37b6-4aa3-b6c9-663bc8d6ab8dProduct name920250103
334fe8d2-68fb-4331-a576-420e302ec069Product name720240320
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
e92765c1-be81-432a-b909-1b10777ec378Product name120190208
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
0441a8f5-3835-497c-aedd-bc78cba56b2aProduct name120150317
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
e89c33e6-9224-49b0-4d80-05239f586f24Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
82450-050-022023-01-30C16284748780-1f386c64a-3b81-0266-e053-dadaa90a7c1a7daf7905-f045-450a-a672-20f17f54b6e0

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82450-050-01ROOTSALLO TOOTHPASTE120 g in 1 TUBEGEL, DENTIFRICE1201
82450-050-02ROOTSALLO TOOTHPASTE1 in 1 CARTONGEL, DENTIFRICE11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82450-050ROOTSALLO TOOTHPASTE (CALCIUM CARBONATE, ALCLOXA, AMINOCAPROIC ACID, DIBASIC CALCIUM PHOSPHATE DIHYDRATE) GEL, DENTIFRICE [ROOTSALLO QWELL]1Legacy NDC, 2 package rows20220104_7daf7905-f045-450a-a672-20f17f54b6e0.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82450-05082450-050-01, 82450-050-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
CALCIUM CARBONATEH0G9379FGKACTIM
ALCLOXA18B8O9DQA2ACTIB
Aminocaproic AcidU6F3787206ACTIB
DIBASIC CALCIUM PHOSPHATE DIHYDRATEO7TSZ97GEPACTIB
SORBITOL506T60A25RIACT
GlycerinPDC6A3C0OXIACT
SILICON DIOXIDEETJ7Z6XBU4IACT

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
d2472689-fc65-4b47-9f19-dc476af733ab7daf7905-f045-450a-a672-20f17f54b6e02021-12-30WarningsExact identifier
spl id: d2472689-fc65-4b47-9f19-dc476af733ab
spl set id: 7daf7905-f045-450a-a672-20f17f54b6e0

Reported adverse events (FAERS/openFDA)#

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