Gelato homecare vivid neutral gel

Active ingredient:

1.1% Sodium Fluoride.


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


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


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.

Storage and handling section

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

Inactive ingredients:

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

Ingredients and appearance - Product information

Gelato homecare vivid neutral gel- Sodium fluoride

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 68400-208
Route of Administration Dental

Active Ingredient/Active Moiety

Ingredient Name Strength
Sodium fluoride ( UNII: 8ZYQ1474W7)( Fluoride ion - UNII: Q80VPU408O ) 0.597 gin 120 g

Inactive Ingredients

Ingredient Name Code
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

Flavor MINT Color white (opaque)

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
unapproved drug other USA

Labeler - Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.( 014769301)


Name ID/FEI Business Operations
Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. 014769301 manufacture( 68400-208), label( 68400-208)

Package label.principal display panel

Package label.principal display panel