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

Image of carton

DELIXIR G TOOTHPASTE 
sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83466-010
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium Fluoride (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.11 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
Sorbitol (UNII: 506T60A25R)  
Water (UNII: 059QF0KO0R)  
Hydrated Silica (UNII: Y6O7T4G8P9)  
Glycerin (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83466-010-021 in 1 CARTON05/01/2023
1NDC:83466-010-01120 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other05/01/2023
Labeler - Froncare, Inc. (040424783)
Registrant - Froncare, Inc. (040424783)
Establishment
NameAddressID/FEIBusiness Operations
DONG IL PHARMS CO., LTD.557810721manufacture(83466-010)

Revised: 5/2023
Document Id: 8e05541f-ad3e-4d77-acc7-babbac907551
Set id: bd210146-9403-45cb-b411-6b90b5c1679f
Version: 1
Effective Time: 20230517
 
Froncare, Inc.