HYDROGEMTOOTHPASTE- calcium hydrogen phosphate hydrate paste, dentifrice

HYDROGEMToothpaste by

Drug Labeling and Warnings

HYDROGEMToothpaste by is a Otc medication manufactured, distributed, or labeled by H2 biohealthcare Co.,Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

calcium hydrogen phosphate hydrate

PURPOSE

■ Prevention of cavities, removal of bad breath, prevention of gum disease

■ Prevention of gingivitis and periodontitis

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

INDICATIONS & USAGE

apply appropriate amount of the tooth paste on the tooth brush and brush the teeth

WARNINGS

For dental use only

When using this product

■ top use and ask a dentist if oral irritation or tooth sensitivity occurs

■ Be careful not to swallow and rinse your mouth thoroughly after use.

■ If any abnormality occurs while using toothpaste, such as damage to the gums or inside of the mouth, stop using it immediately and consult a dentist.

INACTIVE INGREDIENT

L-menthol, glycerin, saccharin sodium hydrate, spearmint oil, xylitol, purified water, sodium carboxymethyl cellulose, cocamidopropyl betaine, propolis

DOSAGE & ADMINISTRATION

For dental use only

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HYDROGEMTOOTHPASTE 
calcium hydrogen phosphate hydrate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83811-0001
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J) (CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS - UNII:L11K75P92J)	CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS	2.14 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
XYLITOL (UNII: VCQ006KQ1E)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83811-0001-1	150 g in 1 TUBE; Type 0: Not a Combination Product	11/20/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		11/20/2023

Labeler - H2 biohealthcare Co.,Ltd (695269509)

Registrant - H2 biohealthcare Co.,Ltd (695269509)

Establishment
Name	Address	ID/FEI	Business Operations
H2 biohealthcare Co.,Ltd		695269509	manufacture(83811-0001)