CAREDO REPAIRING DENTAL CARIES FOR KIDS TOOTHPASTES 50G- repairing dental caries for kids 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 Repairing Dental Caries for Kids Toothpaste, 50g

Active ingredient

hydroxyapatite (0.5%): 0.25g/package.

Inactive ingredient

calcium carbonate (50%): 25g/package;

glycerol (30%): 15g/package;
deionized water (13.5%): 6.75g/package;
sodium lauryl sulfate (2%): 1g/package;
carboxymethyl cellulose (1%): 0.5g/package;

fruit flavoring (1.5%): 0.75g/package;
edible saccharin sodium (0.1%): 0.05g/package;
glutamic acid (0.5%): 0.25g/package;

vitamin C (0.3%): 0.15g/package;

vitamin B (0.3%): 0.15g/package;

vitamin E (0.3%): 0.15g/package;.

Purpose

Eliminates plaque, reverse cavity, etc.

When using

When want to eliminates plaque, reverse cavity, 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 aged 6 or under.

Children six or below should use under adult supervision.

Apply one centimeter (a pea-size amount of) to brush the teeth, then rinse and spit with clear water.

(Swallowing a minor amount will not harm the body)

Questions

Please contact us when you have any questions.

Pregnancy or breast feeding

Pregnant or breast feeding women allowed to use this product.

Indications & usage

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

Dosage & administration

One tube of 50g in one package.

Dosage forms & strengths

It is paste form.
Apply proper as you need.

Warnings

Keep out of reach of children aged 6 or under.
Children six or below should use under adult supervision.
Apply one centimeter (a pea-size amount of) to brush the teeth, then rinse and spit with clear water.
(Swallowing a minor amount will not harm the body)

Package label. Principal display panel

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Container Label

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Package Label

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CAREDO REPAIRING DENTAL CARIES FOR KIDS TOOTHPASTES  50G
repairing dental caries for kids toothpaste paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72415-232
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) (PHOSPHATE ION - UNII:NK08V8K8HR) TRIBASIC CALCIUM PHOSPHATE0.25 g  in 50 g
Inactive Ingredients
Ingredient NameStrength
CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X) 0.5 g  in 50 g
WATER (UNII: 059QF0KO0R) 6.75 g  in 50 g
CALCIUM CARBONATE (UNII: H0G9379FGK) 25 g  in 50 g
SACCHARIN SODIUM (UNII: SB8ZUX40TY) 0.05 g  in 50 g
SODIUM LAURYL SULFATE (UNII: 368GB5141J) 1 g  in 50 g
GLYCERIN (UNII: PDC6A3C0OX) 15 g  in 50 g
MANDARIN OIL (UNII: NJO720F72R) 0.75 g  in 50 g
ASCORBIC ACID (UNII: PQ6CK8PD0R) 0.15 g  in 50 g
GLUTAMIC ACID (UNII: 3KX376GY7L) 0.25 g  in 50 g
PANTOTHENIC ACID (UNII: 19F5HK2737) 0.15 g  in 50 g
.ALPHA.-TOCOPHEROL, D- (UNII: N9PR3490H9) 0.15 g  in 50 g
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72415-232-3050 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 other07/03/201808/13/2018
Labeler - Hong Kong Prosthodontics Medicine Limited (664580884)
Registrant - Hong Kong Prosthodontics Medicine Limited (664580884)
Establishment
NameAddressID/FEIBusiness Operations
Hong Kong Prosthodontics Medicine Limited664580884label(72415-232) , manufacture(72415-232)

Revised: 8/2018
 
Hong Kong Prosthodontics Medicine Limited