FINEFRA AID TOOTH- precipitated calcium carbonate, tocopherol acetate, aluminum chlorohydroxy allantoinate, dibasic calcium phosphate hydrate paste, dentifrice 
Jewoo Medical 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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ACTIVE INGREDIENTS

Precipitated Calcium Carbonate 0.10%
Tocopherol Acetate 0.04%
Aluminum Chlorohydroxy Allantoinate 0.04%
Dibasic Calcium Phosphate Hydrate 0.04%

INACTIVE INGREDIENTS

D-Sorbitol Solution, Purified Water in Bulk, Glycerin, Silica, Sodium Cocoyl Glutamate, Mica, Peppermint Flavor, Active Carbon, Steviol Glycoside, Carboxymethylcellulose Sodium, Chitosan, Xylitol, Grapefruit Seed Extract, Anethole, L-Menthol, Propolis Extract, Scutellaria Root Extract, Sophora Extract, Aloe Extract(09), Gentian Extract, Lavender Extract(1), Rosemary Extract, Mastic Oil, Chamaecyparis Obtusa Oil, Eucalyptus Oil, Glycyrrhiza Extract, Sage Extract, Argentum

PURPOSE

Anticavity

WARNINGS

Keep out of the reach of children under 6 years of age.

If you accidentally swallow more than used for brushing, Seek professional help or contact a poison control center immediately

KEEP OUT OF REACH OF CHILDREN

Keep out of the reach of children under 6 years of age.

Uses

Uses:

Aids in the prevention of cavities, plaque, and gingivitis.

Directions

Directions:

Adults and children 2 yrs. older: Brush teeth thoroughly after meals or at least twice a day, or use as directed by a dentist or physician. Do not swallow. Children under 6 yrs.: To minimize swallowing, use a pea-sized amount and supervise brushing until good habits are established. Children under 2 yrs.: Ask a dentist or physician.

Package Label: Finefra Aid Toothpaste 20g

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Package Label: Finefra Aid Toothpaste 100g

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Package Label: Finefra Aid Toothpaste 135g

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FINEFRA AID TOOTH 
precipitated calcium carbonate, tocopherol acetate, aluminum chlorohydroxy allantoinate, dibasic calcium phosphate hydrate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69653-130
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION0.10 g  in 100 g
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) (.ALPHA.-TOCOPHEROL - UNII:H4N855PNZ1) .ALPHA.-TOCOPHEROL ACETATE0.04 g  in 100 g
ALCLOXA (UNII: 18B8O9DQA2) (ALLANTOIN - UNII:344S277G0Z) ALCLOXA0.04 g  in 100 g
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP) (ANHYDROUS DIBASIC CALCIUM PHOSPHATE - UNII:L11K75P92J) DIBASIC CALCIUM PHOSPHATE DIHYDRATE0.04 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
SORBITOL (UNII: 506T60A25R)  
Water (UNII: 059QF0KO0R)  
Glycerin (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69653-130-0120 g in 1 TUBE; Type 0: Not a Combination Product05/01/2020
2NDC:69653-130-02100 g in 1 CARTON; Type 0: Not a Combination Product05/01/2020
3NDC:69653-130-03135 g in 1 CARTON; Type 0: Not a Combination Product05/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other05/01/2020
Labeler - Jewoo Medical Co,.Ltd (689512541)
Registrant - Jewoo Medical Co,.Ltd (689512541)
Establishment
NameAddressID/FEIBusiness Operations
Woorilife&Health694860803manufacture(69653-130)

Revised: 6/2020
Document Id: bc4e2efb-b5b4-4273-82ef-eac710260d39
Set id: b82ec80b-87a6-4670-b139-775e6028b62f
Version: 1
Effective Time: 20200603
 
Jewoo Medical Co,.Ltd