SORBET HOMECARE- stannous fluoride gel 
Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.

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Active Ingredient:

Stannous Fluoride 0.4%

Purpose:

Fluoride preventive treatment gel

Uses:

Warnings:

Directions:

Adults and children 6 years of age and older: Twist off cap to remove foil seal. Use once a day after brushing your teeth with a toothpaste. Apply the gel to your teeth and brush thoroughly. Allow the gel to remain on your teeth for 1 minute and then spit out. Do not swallow the gel. Do not eat or drink for 30 minutes after brushing. Instruct children under 12 years of age in the use of this product (to minimize swallowing). Supervise children as necessary until capable of using without supervision. Children under 6 years of age: consult a dentist or doctor.

Other Information:

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

Inactive Ingredients:

Carbopol, Flavor, Glycerine, Malic Acid, Sodium Carboxymethylcellulose, Water, Xanthan Gum.

Questions or comments?

1-800-333-3131

www.keystoneind.com

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SORBET HOMECARE 
stannous fluoride gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68400-800
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
STANNOUS FLUORIDE (UNII: 3FTR44B32Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.116 g  in 120 g
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
MALIC ACID (UNII: 817L1N4CKP)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
Colorwhite (cloudy) Score    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68400-800-04120 g in 1 TUBE; Type 0: Not a Combination Product03/01/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Export only01/05/2013
Labeler - Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. (014769301)
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.014769301manufacture(68400-800) , label(68400-800)

Revised: 4/2024
Document Id: 16dce3ea-b967-24fe-e063-6394a90a1c18
Set id: ffa07f25-df38-447e-92db-0fbd001eab05
Version: 6
Effective Time: 20240424
 
Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.