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

Finefra Aid Tooth by

Drug Labeling and Warnings

Finefra Aid Tooth by is a Otc medication manufactured, distributed, or labeled by Jewoo Medical Co,.Ltd, Woorilife&Health. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

Package Label: Finefra Aid Toothpaste 100g

Package Label: Finefra Aid Toothpaste 135g

INGREDIENTS AND APPEARANCE

FINEFRA AID TOOTH 
precipitated calcium carbonate, tocopherol acetate, aluminum chlorohydroxy allantoinate, dibasic calcium phosphate hydrate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69653-130
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM CATION	0.10 g  in 100 g
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) (.ALPHA.-TOCOPHEROL - UNII:H4N855PNZ1)	.ALPHA.-TOCOPHEROL ACETATE	0.04 g  in 100 g
ALCLOXA (UNII: 18B8O9DQA2) (ALLANTOIN - UNII:344S277G0Z)	ALCLOXA	0.04 g  in 100 g
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP) (ANHYDROUS DIBASIC CALCIUM PHOSPHATE - UNII:L11K75P92J)	DIBASIC CALCIUM PHOSPHATE DIHYDRATE	0.04 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
SORBITOL (UNII: 506T60A25R)
Water (UNII: 059QF0KO0R)
Glycerin (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69653-130-01	20 g in 1 TUBE; Type 0: Not a Combination Product	05/01/2020
2	NDC: 69653-130-02	100 g in 1 CARTON; Type 0: Not a Combination Product	05/01/2020
3	NDC: 69653-130-03	135 g in 1 CARTON; Type 0: Not a Combination Product	05/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		05/01/2020

Labeler - Jewoo Medical Co,.Ltd (689512541)

Registrant - Jewoo Medical Co,.Ltd (689512541)

Establishment
Name	Address	ID/FEI	Business Operations
Woorilife&Health		694860803	manufacture(69653-130)