DR. ZENNI NATURAL WHITETOOTHPASTE- sodium monofluorophosphate paste, dentifrice

Dr. Zenni Natural WhiteToothpaste by

Drug Labeling and Warnings

Dr. Zenni Natural WhiteToothpaste by is a Otc medication manufactured, distributed, or labeled by Zeniton Co.,Ltd., DONG IL PHARMS CO., LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Sodium Monofluorophosphate 0.75%

PURPOSE

Anticavity

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

Uses

■ Helps protect against cavities
■ Removal of plaque

WARNINGS

Keep out or reach of children under 6 yrs. of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

INACTIVE INGREDIENTS

D-Sorbitol Solution, Precipitated Calcium Carbonate, Water, Hydroxyapatite, Concentrated Glycerin, Sodium Cocoyl Glutamate, Xanthangum, Xylitol, Lime Flavor, Apple Mint Flavor, Grapefruit Seed Extract, Peppermint Oil, Sodium Chloride, Chamomile Extract, Sage Extract, Aloe Extract, Eucalyptus Extract, Tocopherol Acetate, Green Tea Extract

Directions

■ Adults and children 2 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 doctor.
■ Children under 6 years: To minimize swallowing, use a pea-sized amount and supervise brushing until good habits are established.
■ Children under 2 years: Consult a dentist or doctor.

Other Information

■ Do not store this product in an inappropriate place such as high or low temperatures or under direct sun light (1~30℃)

QUESTIONS

■ www.zeniton.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DR. ZENNI NATURAL WHITETOOTHPASTE 
sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73029-0013
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.7581 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
XYLITOL (UNII: VCQ006KQ1E)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73029-0013-1	100 g in 1 TUBE; Type 0: Not a Combination Product	11/22/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	11/22/2020

Labeler - Zeniton Co.,Ltd. (688416831)

Registrant - Zeniton Co.,Ltd. (688416831)

Establishment
Name	Address	ID/FEI	Business Operations
DONG IL PHARMS CO., LTD.		557810721	manufacture(73029-0013)