HYDROGEMTOOTHPASTE- calcium hydrogen phosphate hydrate paste, dentifrice 
H2 biohealthcare Co.,Ltd

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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calcium hydrogen phosphate hydrate

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

■ Prevention of gingivitis and periodontitis

Keep out of reach of children

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

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.

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

For dental use only

label

HYDROGEMTOOTHPASTE 
calcium hydrogen phosphate hydrate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83811-0001
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J) (CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS - UNII:L11K75P92J) CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS2.14 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
XYLITOL (UNII: VCQ006KQ1E)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83811-0001-1150 g in 1 TUBE; Type 0: Not a Combination Product11/20/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other11/20/2023
Labeler - H2 biohealthcare Co.,Ltd (695269509)
Registrant - H2 biohealthcare Co.,Ltd (695269509)
Establishment
NameAddressID/FEIBusiness Operations
H2 biohealthcare Co.,Ltd695269509manufacture(83811-0001)

Revised: 11/2023
Document Id: 0a8abb63-d312-2f26-e063-6294a90a7896
Set id: 0a8ad5fa-49cc-4576-e063-6394a90a5d13
Version: 1
Effective Time: 20231119
 
H2 biohealthcare Co.,Ltd