Label: FLUORIDE- toothpaste tablets tablet, chewable
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Contains inactivated NDC Code(s)
NDC Code(s): 80143-001-01, 80143-001-02, 80143-001-03, 80143-001-04, view more80143-001-05, 80143-001-06, 80143-001-07, 80143-001-08, 80143-001-09, 80143-001-10, 80143-001-11, 80143-001-12 - Packager: Henan Dailygreen Trade Co.,Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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 19, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Uses
- Warnings
- KEEP OUT OF REACH OF CHILDREN
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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
- Inactive Ingredients
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
FLUORIDE
toothpaste tablets tablet, chewableProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:80143-001 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.00145 Inactive Ingredients Ingredient Name Strength 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 Color white (None) Score score with uneven pieces Shape ROUND (None) Size 11mm Flavor MINT (None) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:80143-001-01 60 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 06/24/2020 2 NDC:80143-001-02 62 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 06/24/2020 3 NDC:80143-001-03 120 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 06/24/2020 4 NDC:80143-001-04 60 in 1 TUBE; Type 0: Not a Combination Product 06/24/2020 5 NDC:80143-001-05 90 in 1 TUBE; Type 0: Not a Combination Product 06/24/2020 6 NDC:80143-001-06 120 in 1 TUBE; Type 0: Not a Combination Product 06/24/2020 7 NDC:80143-001-07 30 in 1 CARTON; Type 0: Not a Combination Product 06/24/2020 8 NDC:80143-001-08 60 in 1 CARTON; Type 0: Not a Combination Product 06/24/2020 9 NDC:80143-001-09 2 in 1 BAG; Type 0: Not a Combination Product 06/24/2020 10 NDC:80143-001-10 62 in 1 BAG; Type 0: Not a Combination Product 06/24/2020 11 NDC:80143-001-11 120 in 1 BAG; Type 0: Not a Combination Product 06/24/2020 12 NDC:80143-001-12 1000 in 1 BAG; Type 0: Not a Combination Product 06/24/2020 
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 06/24/2020 Labeler - Henan Dailygreen Trade Co.,Ltd. (554544781) Registrant - Henan Dailygreen Trade Co.,Ltd. (554544781) Establishment Name Address ID/FEI Business Operations Henan Dailygreen Trade Co.,Ltd. 554544781 manufacture(80143-001) , label(80143-001) , pack(80143-001)
