FDA.reportPublic FDA data

GZE TOOTHPASTE TABLETS

Manufacturer
Guangzhou Yilong Cosmetics Co., Ltd
Effective date
2024-08-30
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:18:18

Label at a glance#

ProductGze ToothpasteTablets
Active ingredientMENTHOL, CLOVE OIL
Label structure11 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Menthol 0.6%

Eugenia Caryophyllus (Clove) Leaf Oil 5%

INACTIVE INGREDIENT SECTION

Sorbitol

Calcium Carbonate

Kaolin

Sodium Bicarbonate

Mentha Piperita (Peppermint) Oil

Stevia Rebaudiana Leaf Extract

Flavor

OTC - PURPOSE SECTION

Oral cleaning

INDICATIONS & USAGE SECTION

Chew one tablet until it turns into a paste-like consistency. Wet your toothbrush and brush your teeth as usual with the toothpaste tablet paste. Rinse your mouth thoroughly with water.

WARNINGS SECTION

For external use only.

OTC - STOP USE SECTION

Stop use and ask a doctor if rash occurs.

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin.

OTC - WHEN USING SECTION

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

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.

DOSAGE & ADMINISTRATION SECTION

Chew one tablet until it turns into a paste-like consistency. Wet your toothbrush and brush your teeth as usual with the toothpaste tablet paste. Rinse your mouth thoroughly with water.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

product imageproduct imagelabellabel

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83566-320-01Gze ToothpasteTablets18 g in 1 BOTTLETABLET, CHEWABLE181

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83566-320GZE TOOTHPASTETABLETS (EUGENIA CARYOPHYLLUS (CLOVE) LEAF OIL,MENTHOL) TABLET, CHEWABLE [GUANGZHOU YILONG COSMETICS CO., LTD]11 package rows20240831_20e4d9f9-f423-edf8-e063-6394a90a67a8.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83566-32083566-320-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
MENTHOLL7T10EIP3AACTIB
STEVIA REBAUDIANA LEAF6TC6NN0876IACT
SORBITOL506T60A25RIACT
CALCIUM CARBONATEH0G9379FGKIACT
KAOLIN24H4NWX5COIACT
SODIUM BICARBONATE8MDF5V39QOIACT
CLOVE OIL578389D6D0ACTIB
PEPPERMINT OILAV092KU4JHIACT

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
20e4d9f9-f424-edf8-e063-6394a90a67a820e4d9f9-f423-edf8-e063-6394a90a67a82024-08-30WarningsExact identifier
spl id: 20e4d9f9-f424-edf8-e063-6394a90a67a8
spl set id: 20e4d9f9-f423-edf8-e063-6394a90a67a8

Reported adverse events (FAERS/openFDA)#

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