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NDC 72415-0215-50 CAREDO Repair Cracked Teeth Toothpastes 0.5 g/100g Details

CAREDO Repair Cracked Teeth Toothpastes 0.5 g/100g

CAREDO Repair Cracked Teeth Toothpastes is a DENTAL PASTE, DENTIFRICE in the HUMAN OTC DRUG category. It is labeled and distributed by Hong Kong Prosthodontics Medicine Limited. The primary component is GLYCINE.

Product Information

NDC	72415-0215
Product ID	72415-215_70115237-0d56-3986-e053-2a91aa0a7be9
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	CAREDO Repair Cracked Teeth Toothpastes
Proprietary Name Suffix	100g
Non-Proprietary Name	Repair Cracked Teeth Toothpaste
Product Type	HUMAN OTC DRUG
Dosage Form	PASTE, DENTIFRICE
Route	DENTAL
Active Ingredient Strength	0.5
Active Ingredient Units	g/100g
Substance Name	GLYCINE
Labeler Name	Hong Kong Prosthodontics Medicine Limited
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	UNAPPROVED DRUG OTHER
Application Number	n/a
Listing Certified Through	2023-12-31

Package

Package Images

NDC 72415-0215-50 (72415021550)

Pricing Information	N/A
NDC Package Code	72415-215-50
Billing NDC	72415021550
Package	100 g in 1 TUBE (72415-215-50)
Marketing Start Date	2018-07-03
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 70115237-0d67-3986-e053-2a91aa0a7be9 Details

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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Container Label

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Package Label

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INGREDIENTS AND APPEARANCE

CAREDO REPAIR CRACKED TEETH TOOTHPASTES 100G

repair cracked teeth toothpaste paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:72415-215
Route of Administration	DENTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
GLYCINE (UNII: TE7660XO1C) (GLYCINE - UNII:TE7660XO1C)	GLYCINE	0.5 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:72415-215-50	100 g in 1 TUBE; Type 0: Not a Combination Product	07/03/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		07/03/2018

Labeler - Hong Kong Prosthodontics Medicine Limited (664580884)

Registrant - Hong Kong Prosthodontics Medicine Limited (664580884)

Name	Address	ID/FEI	Business Operations
Establishment
Hong Kong Prosthodontics Medicine Limited		664580884	label(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