GZE TOOTHPASTETABLETS (eugenia caryophyllus- clove leaf oil,menthol tablet, chewable

Gze ToothpasteTablets by

Drug Labeling and Warnings

Gze ToothpasteTablets by is a Otc medication manufactured, distributed, or labeled by Guangzhou Yilong Cosmetics Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Menthol 0.6%

Eugenia Caryophyllus (Clove) Leaf Oil 5%

INACTIVE INGREDIENT

Sorbitol

Calcium Carbonate

Kaolin

Sodium Bicarbonate

Mentha Piperita (Peppermint) Oil

Stevia Rebaudiana Leaf Extract

Flavor

PURPOSE

Oral cleaning

INDICATIONS & USAGE

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

For external use only.

STOP USE

Stop use and ask a doctor if rash occurs.

DO NOT USE

Do not use on damaged or broken skin.

WHEN USING

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

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

GZE TOOTHPASTETABLETS 
eugenia caryophyllus (clove) leaf oil,menthol tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83566-320
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.6 g  in 100 g
CLOVE OIL (UNII: 578389D6D0) (CLOVE OIL - UNII:578389D6D0)	CLOVE OIL	5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
STEVIA REBAUDIANA LEAF (UNII: 6TC6NN0876)
SORBITOL (UNII: 506T60A25R)
CALCIUM CARBONATE (UNII: H0G9379FGK)
KAOLIN (UNII: 24H4NWX5CO)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
PEPPERMINT OIL (UNII: AV092KU4JH)

Product Characteristics
Color	green	Score	no score
Shape	ROUND	Size	11mm
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83566-320-01	18 g in 1 BOTTLE; Type 0: Not a Combination Product	08/18/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M022	08/18/2024

Labeler - Guangzhou Yilong Cosmetics Co., Ltd (712647107)

Establishment
Name	Address	ID/FEI	Business Operations
Guangzhou Yilong Cosmetics Co., Ltd		712647107	manufacture(83566-320)