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Sorbet Neutral

Generic Name: sodium fluoride
Dosage Form: dental gel

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.

Active Ingredient:

1.1% Sodium Fluoride.

Uses:

Aids in prevention of dental caries and hypersensitivity. Use as directed by your dentist.

Warnings:

Do not swallow. To avoid ingestion, supervision is required while children are using the product. Keep out of reach of children.

Directions:

Adults and children 6 years of age and older:

  • Twist off cap to remove foil seal.
  • Use once daily after brushing teeth thoroughly with toothpaste.
  • Apply a small amount to a toothbrush and brush thoroughly on all tooth surfaces for at least 1 minute.
  • Expectorate, do not swallow, do not eat, drink or rinse for at least 30 minutes.

Children under 6 years of age:

  • Consult a dentist or physcian.

Store at controlled room temperature 59° - 86°F (15° - 30°C).

Inactive Ingredients:

Calcium Caseinate, Citric Acid, Flavor, Glycerine, Glydant, Sodium Benzoate, Sodium Hexameta Phosphate, Sodium Saccharine, TriCalcium Phosphate, Vitamin E, Water, Xanthan Gum, Xylitol.

Sorbet Neutral 
sodium fluoride gel
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:68400-850
Route of Administration DENTAL, TOPICAL, ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION 1.32 g  in 120 g
Inactive Ingredients
Ingredient Name Strength
CASEIN  
CITRIC ACID MONOHYDRATE  
GLYCERIN  
DMDM HYDANTOIN  
SODIUM BENZOATE  
SODIUM POLYMETAPHOSPHATE  
SACCHARIN SODIUM  
TRICALCIUM PHOSPHATE  
.ALPHA.-TOCOPHEROL  
WATER  
XANTHAN GUM  
XYLITOL  
Product Characteristics
Color      Score     
Shape Size
Flavor MINT Imprint Code
Contains         
Packaging
# Item Code Package Description
1 NDC:68400-850-04 120 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 03/15/2013
Labeler - Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. (078654194)
Registrant - Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. (014769301)
Establishment
Name Address ID/FEI Operations
Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. 078654194 manufacture(68400-850), label(68400-850)
Revised: 08/2013
 
Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.



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