UNIQUE PROPOLI TOOTHPAS TE- silicon dioxide, tocopherol acetate paste

Unique Propoli Toothpas te by

Drug Labeling and Warnings

Unique Propoli Toothpas te by is a Otc medication manufactured, distributed, or labeled by Unique Biotech.,Co.Ltd, Kolmar Korea Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients: Silicon Dioxide 8.0%, Tocopherol Acetate 0.14%

INACTIVE INGREDIENT

Inactive ingredients:

D-Sorbitol solution, Purified water, Hydrated silica, Sodium lauryl sulfate, Polyethylene glycol1500, Carboxymethylcellulose sodium, L-menthol, Herb mint flavor B71389, Lemon essence F-L95, Propolis extracts, Titanium oxide, Cool mint flavor HF-61399, Steviol glucoside, Xylitol, Hydroxyapatite, Sage extract, Chamomile extract, Methylparaben, Green tea extract.

PURPOSE

Purpose: Antibacterial and anticavity

WARNINGS

Warnings:

Keep out of the reach of children under 5 years of age.

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

KEEP OUT OF REACH OF CHILDREN

Keep out of the reach of children under 5 years of age.

Uses

Uses:

- Delivering all features including anti-plague, anti-septic & anti-bacterial properties, gingivitis, cavities reduction and mouth & gums.

Directions

Directions:

Adults and children 6 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician

Children 2 to 6 years: Use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing)

Children under 2 years: Ask a dentist or physician

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

UNIQUE PROPOLI TOOTHPAS TE 
silicon dioxide, tocopherol acetate paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72537-010
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4)	SILICON DIOXIDE	9.6 g  in 120 g
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) (.ALPHA.-TOCOPHEROL - UNII:H4N855PNZ1)	.ALPHA.-TOCOPHEROL ACETATE	0.16 g  in 120 g

Inactive Ingredients
Ingredient Name	Strength
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72537-010-02	1 in 1 CARTON	08/01/2018
1	NDC: 72537-010-01	120 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		08/01/2018

Labeler - Unique Biotech.,Co.Ltd (688896374)

Registrant - Unique Biotech.,Co.Ltd (688896374)

Establishment
Name	Address	ID/FEI	Business Operations
Kolmar Korea Co., Ltd.		688732723	manufacture(72537-010)