Delixir G Toothpaste by Froncare, Inc. / DONG IL PHARMS CO., LTD.

Delixir G Toothpaste by

Drug Labeling and Warnings

Delixir G Toothpaste by is a Otc medication manufactured, distributed, or labeled by Froncare, Inc., DONG IL PHARMS CO., LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DELIXIR G TOOTHPASTE- sodium fluoride paste, dentifrice 
Froncare, Inc.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Active ingredient

Sodium Fluoride 0.11%

Inactive ingredients

Sorbitol, Water, Hydrated Silica, Glycerin, Hydroxyapatite, Tetrasodium Pyrophosphate, Xylitol, Cellulose Gum, Sodium Cocoyl Glutamate, Rubus Idaeus Fruit Extract, Sodium Methyl Cocoyl Taurate, Floral Flavor, Stevioside, Tocopheryl Acetate, Centella Asiatica Extract, Sodium Chloride, Floral Mint Flavor, Chamomilla Recutita Flower Extract, Salvia Officinalis Leaf Extract, Eucalyptus Globulus Leaf Extract, Lactuca Scariola Sativa Leaf Extract, Bioactive Herb Complex-C, Myrrha Essence, Menthol, Malt Extract

Purpose

Anti cavity

Warnings

■ Rinse the mouth thoroughly after use.
■ Keep out of the reach of children under 6 years of age.
■ If you accidentally swallow more than used for brushing, get medical help or contact a Poison Control Center immediately.

KEEP OUT OF REACH OF CHILDREN

■ Keep out of the reach of children under 6 years of age.

Use(s)

■ Aids in the prevention of dental cavities.
■ Keeps your teeth strong.
■ Keeps your mouth clean.
■ Refreshes the inside of the mouth.
■ Removes bad breath.
■ Increases aesthetic effect.
■ Prevents periodontal disease.
■ Removal of plaque(anti-plaque)

Directions

■ Apply a pea-sized amount of toothpaste on the brush. Brush teeth thoroughly after each meal or at least twice a day.

Other Information

■ Store below 30℃ (86℉)

Questions

■ 1-929-800-1016

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DELIXIR G TOOTHPASTE 
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83466-010
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.11 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83466-010-02	1 in 1 CARTON	05/01/2023	08/30/2023
1	NDC: 83466-010-01	120 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		05/01/2023	08/30/2023

Labeler - Froncare, Inc. (040424783)

Registrant - Froncare, Inc. (040424783)

Establishment
Name	Address	ID/FEI	Business Operations
DONG IL PHARMS CO., LTD.		557810721	manufacture(83466-010)

Revised: 6/2025

Document Id: 37478c85-072d-ae51-e063-6394a90a588f

34390-5

Set id: bd210146-9403-45cb-b411-6b90b5c1679f

Version: 3

Effective Time: 20250611