SORBET NEUTRAL- sodium fluoride gel 
Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products 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:

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.

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SORBET NEUTRAL 
sodium fluoride gel
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:68400-850
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.597 g  in 120 g
Inactive Ingredients
Ingredient NameStrength
CASEIN (UNII: 48268V50D5)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
GLYCERIN (UNII: PDC6A3C0OX)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
TRICALCIUM PHOSPHATE (UNII: K4C08XP666)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
WATER (UNII: 059QF0KO0R)  
XANTHAN GUM (UNII: TTV12P4NEE)  
XYLITOL (UNII: VCQ006KQ1E)  
Product Characteristics
Colorwhite (opaque) Score    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68400-850-04120 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other03/15/2013
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
NameAddressID/FEIBusiness Operations
Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.078654194manufacture(68400-850) , label(68400-850)

Revised: 11/2013
 
Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.