ORALHOE PROBIOTIC BRIGHTENING- glycerin cream

ORALHOE Probiotic Brightening by

Drug Labeling and Warnings

ORALHOE Probiotic Brightening by is a Otc medication manufactured, distributed, or labeled by Guangdong Ximonth Technology Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient(s)

XYLITOL、PROPOLIS EXTRACT、MENTHA PIPERITA (PEPPERMINT)EXTRACT、CHRYSANTHELLUM INDICUM EXTRACT

Purpose

1.Reduce oral odour, make breath fresh and pleasant, increase oral comfort.
2.Effectively removes tea stains, coffee stains and other pigmentation on the surface of the teeth, making the teeth whiter and brighter.
3. Prevents tooth decay, helps to protect the health of teeth and gums.
4. Safe and gentle ingredients, suitable for everyone, including people with sensitive teeth.

Use

1. Take an appropriate amount of toothpaste on the toothbrush
2. Use the correct way to brush for 2-3 minutes
3. Rinse your mouth with water

Warnings

Please keep out of reach of children.Do not swallow.Please clean your hands before use to ensure the best results from the product.Discontinue use if signs of irritation or rash occur.Store in a cool and dry place.

Do not use

Discontinue use if signs of irritation or rash occur.

STOP USE

Discontinue use if signs of irritation or rash occur.

KEEP OUT OF REACH OF CHILDREN

Please keep out of reach of children. Do not swallow.

STORAGE AND HANDLING

Avoid freezing and excessive heat above 40C (104F) ）
Store in a cool and dry place.

INACTIVE INGREDIENT

GLYCERIN

DOSAGE & ADMINISTRATION

INDICATIONS & USAGE

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ORALHOE PROBIOTIC BRIGHTENING 
glycerin cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84660-036
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHA X PIPERITA WHOLE (UNII: 79M2M2UDA9) (MENTHA X PIPERITA WHOLE - UNII:79M2M2UDA9)	MENTHA X PIPERITA WHOLE	18 g  in 120 g
CHRYSANTHELLUM INDICUM TOP (UNII: STJ856D1Z0) (CHRYSANTHELLUM INDICUM TOP - UNII:STJ856D1Z0)	CHRYSANTHELLUM INDICUM TOP	12 g  in 120 g
XYLITOL (UNII: VCQ006KQ1E) (XYLITOL - UNII:VCQ006KQ1E)	XYLITOL	30 g  in 120 g
PROPOLIS WAX (UNII: 6Y8XYV2NOF) (PROPOLIS WAX - UNII:6Y8XYV2NOF)	PROPOLIS WAX	24 g  in 120 g

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)	36 g  in 120 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84660-036-01	120 g in 1 BOX; Type 0: Not a Combination Product	09/27/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M022	09/27/2024

Labeler - Guangdong Ximonth Technology Co., Ltd. (699436264)

Registrant - Guangdong Ximonth Technology Co., Ltd. (699436264)

Establishment
Name	Address	ID/FEI	Business Operations
Guangdong Ximonth Technology Co., Ltd.		699436264	manufacture(84660-036)