CAREDO REPAIR CRACKED TEETH TOOTHPASTES 100G- repair cracked teeth toothpaste paste, dentifrice 
Hong Kong Prosthodontics Medicine Limited

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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CAREDO Repair Cracked Teeth Toothpaste, 100g

Active ingredient

glycine (0.5%): 0.5g/package.

Inactive ingredient

calcium carbonate (50%): 50g/package;

glycerol (30%): 30g/package;
deionized water (14.9%): 14.9g/package;
sodium lauryl sulfate (2%): 2g/package;
carboxymethyl cellulose (1%): 1g/package;
edible saccharin sodium (0.1%): 0.1g/package;
spearmint flavoring (1.5%): 1.5g/package;

Purpose

Repair and heal cracked teeth, cracks caused by abrasion, root fissures, etc.

When using

When tooth occurs cracked, cracks caused by abrasion, or root fissures, etc..

Do not use

Do not use when oral infection.
It should be cautiously used if you are kind of allergic constitution or you have inflammation.

Stop use

If irritation or discomfort occurs, discontinue the use and consult a physician.

Ask doctor

If irritation or discomfort occurs, discontinue the use and consult a physician.

Ask doctor/pharmacist

Ask doctor/pharmacist when you current use other drugs.

Keep out of reach of children

Keep out of reach of children.

Questions

Please contact us when you have any questions.

Pregnancy or breast feeding

Pregnant or breast feeding women shall follow doctor advice.

Indications & usage

Apply properly this product on the toothbrush, and brush tooth as like common do.

Dosage & administration

One tube of 100g in one package.

Dosage forms & strengths

It is paste form.
Apply proper as you need.

Warnings

In the event of a toothache, children aged 10 or under should use 1cm (a pea-size amount) of toothpaste. Brush the affected area lightly and for short intervals; resume normal practices in the treatment of other teeth.

Package label. Principal display panel

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Package Label

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CAREDO REPAIR CRACKED TEETH TOOTHPASTES  100G
repair cracked teeth toothpaste paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72415-215
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
GLYCINE (UNII: TE7660XO1C) (GLYCINE - UNII:TE7660XO1C) GLYCINE0.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X) 1 g  in 100 g
WATER (UNII: 059QF0KO0R) 14.9 g  in 100 g
CALCIUM CARBONATE (UNII: H0G9379FGK) 50 g  in 100 g
SACCHARIN SODIUM (UNII: SB8ZUX40TY) 0.1 g  in 100 g
SODIUM LAURYL SULFATE (UNII: 368GB5141J) 2 g  in 100 g
GLYCERIN (UNII: PDC6A3C0OX) 30 g  in 100 g
SPEARMINT OIL (UNII: C3M81465G5) 1.5 g  in 100 g
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72415-215-50100 g in 1 TUBE; Type 0: Not a Combination Product07/03/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other07/03/2018
Labeler - Hong Kong Prosthodontics Medicine Limited (664580884)
Registrant - Hong Kong Prosthodontics Medicine Limited (664580884)
Establishment
NameAddressID/FEIBusiness Operations
Hong Kong Prosthodontics Medicine Limited664580884label(72415-215) , manufacture(72415-215)

Revised: 7/2018
Document Id: 70115237-0d56-3986-e053-2a91aa0a7be9
Set id: 70115237-0d67-3986-e053-2a91aa0a7be9
Version: 1
Effective Time: 20180703
 
Hong Kong Prosthodontics Medicine Limited