FLUORIDE- toothpaste tablets tablet, chewable 
Henan Dailygreen Trade 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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Fluoride Toothpaste Tablets

Active ingredient

Sodium Fluoride 0.145%

Purpose

Anticaries

Uses

Aids in the prevention of dental cavities

Warnings

˙ Keep out of reach of children under 6 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 under 6 years of age.

Directions

1. Chew: Place tablet in mouth and chew for 5 seconds.
2. Hydrate: Use a wet brush to moisten the toothpaste in your mouth and brush teeth.

3. Brush: Brush for at least 30 seconds. Rinse and spit out thoroughly. Brush teeth, preferably after each meal or at least twice a day, or as directed by a dentist or doctor. Instruct children under 12 years of age in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision. Children under 6 years of age: Do not use unless directed by a dentist or doctor.

Other Information

Store in room temperature. Avoid direct sunlight.

Shelf life: 3 years.

Production Date: as shown in the packing

Website: www.dailygreen.en.alibaba.com

Inactive Ingredients

Microcrystalline Cellulose, Xylitol, Erythritol, Natural Mint Flavor, Calcium Carbonate, SodiumCocoyl Isethionate, Sodium Bicarbonate, Laurel Extract, Cooling Oil

60 tablets / glass bottle: NDC: 80143-001-01

62 tablets / glass bottle: NDC: 80143-001-02

120 tablets / glass bottle: NDC: 80143-001-03

glass bottle

60 tablets / paper tube: NDC: 80143-001-04

90 tablets / paper tube: NDC: 80143-001-05

120 tablets / paper tube: NDC: 80143-001-06

paper tube

30 tablets / carton: NDC: 80143-001-07

60 tablets / carton: NDC: 80143-001-08

carton

2 tablets / bag: NDC: 80143-001-09

62 tablets / bag: NDC: 80143-001-10

120 tablets / bag: NDC: 80143-001-11

1000 tablets / bag: NDC: 80143-001-12

bag

FLUORIDE 
toothpaste tablets tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80143-001
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.00145 
Inactive Ingredients
Ingredient NameStrength
XYLITOL (UNII: VCQ006KQ1E) 0.51012 
OLEIC ACID (UNII: 2UMI9U37CP) 0.005 
SODIUM BICARBONATE (UNII: 8MDF5V39QO) 0.03 
CALCIUM CARBONATE (UNII: H0G9379FGK) 0.05 
SODIUM ISETHIONATE (UNII: 3R36J71C17) 0.3 
ERYTHRITOL (UNII: RA96B954X6) 0.03 
RACEMENTHOL (UNII: YS08XHA860) 0.00343 
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) 0.06 
MYRCENE (UNII: 3M39CZS25B) 0.01 
Product Characteristics
Colorwhite (None) Scorescore with uneven pieces
ShapeROUND (None) Size11mm
FlavorMINT (None) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80143-001-0160 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product06/24/2020
2NDC:80143-001-0262 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product06/24/2020
3NDC:80143-001-03120 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product06/24/2020
4NDC:80143-001-0460 in 1 TUBE; Type 0: Not a Combination Product06/24/2020
5NDC:80143-001-0590 in 1 TUBE; Type 0: Not a Combination Product06/24/2020
6NDC:80143-001-06120 in 1 TUBE; Type 0: Not a Combination Product06/24/2020
7NDC:80143-001-0730 in 1 CARTON; Type 0: Not a Combination Product06/24/2020
8NDC:80143-001-0860 in 1 CARTON; Type 0: Not a Combination Product06/24/2020
9NDC:80143-001-092 in 1 BAG; Type 0: Not a Combination Product06/24/2020
10NDC:80143-001-1062 in 1 BAG; Type 0: Not a Combination Product06/24/2020
11NDC:80143-001-11120 in 1 BAG; Type 0: Not a Combination Product06/24/2020
12NDC:80143-001-121000 in 1 BAG; Type 0: Not a Combination Product06/24/2020
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35506/24/2020
Labeler - Henan Dailygreen Trade Co.,Ltd. (554544781)
Registrant - Henan Dailygreen Trade Co.,Ltd. (554544781)
Establishment
NameAddressID/FEIBusiness Operations
Henan Dailygreen Trade Co.,Ltd.554544781manufacture(80143-001) , label(80143-001) , pack(80143-001)

Revised: 12/2021
Document Id: d3882ed7-e342-0e8d-e053-2a95a90ac369
Set id: ad447c9a-6f0f-7fef-e053-2995a90a055f
Version: 3
Effective Time: 20211219
 
Henan Dailygreen Trade Co.,Ltd.