DR. ZENNI NATURAL ORTHODONTICTOOTHPASTE- sodium monofluorophosphate paste, dentifrice

Dr. Zenni Natural OrthodonticToothpaste by

Drug Labeling and Warnings

Dr. Zenni Natural OrthodonticToothpaste 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, Water, Silicon Dioxide, Concentrated Glycerin, Hydroxyapatite, Sodium Cocoyl Glutamate, Xanthangum, Red Wine Flavor, Xylitol, L-Menthol, Peppermint Oil, Aminocaproic Acid, Aluminum Chlorohydroxy Allantoinate, Grapefruit Seed Extract, Green Tea Extract, Chamomile Extract, Sage Extract, Aloe Extract, Eucalyptus Extract, Sodium Chloride, Tocopherol Acetate

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 ORTHODONTICTOOTHPASTE 
sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73029-0012
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: 73029-0012-1	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(73029-0012)