DR. ZENNI NATURAL ORTHODONTICTOOTHPASTE- sodium monofluorophosphate paste, dentifrice 
Zeniton Co.,Ltd.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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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

Image of carton

DR. ZENNI NATURAL ORTHODONTICTOOTHPASTE 
sodium monofluorophosphate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73029-0012
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.7581 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
XYLITOL (UNII: VCQ006KQ1E)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73029-0012-1100 g in 1 TUBE; Type 0: Not a Combination Product11/22/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35511/22/2020
Labeler - Zeniton Co.,Ltd. (688416831)
Registrant - Zeniton Co.,Ltd. (688416831)
Establishment
NameAddressID/FEIBusiness Operations
DONG IL PHARMS CO., LTD.557810721manufacture(73029-0012)

Revised: 12/2021
Document Id: 1e33c52b-0b9a-49b2-a71e-a30209094b5b
Set id: b4ada907-5d3a-31a3-e053-2a95a90a7ade
Version: 2
Effective Time: 20211228
 
Zeniton Co.,Ltd.