Label: DR. ZENNI NATURAL ORTHODONTICTOOTHPASTE- sodium monofluorophosphate paste, dentifrice
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Contains inactivated NDC Code(s)
NDC Code(s): 73029-0012-1 - Packager: Zeniton Co.,Ltd.
- Category: HUMAN OTC DRUG LABEL
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.
Drug Label Information
Updated December 28, 2021
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- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- Uses
- WARNINGS
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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
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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
- Questions
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
DR. ZENNI NATURAL ORTHODONTICTOOTHPASTE
sodium monofluorophosphate paste, dentifriceProduct 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)