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

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Active Ingredient

Stannous Fluoride 0.4%

Purpose

Fluoride preventive treatment gel

Uses

Warning

  • Keep out of reach of children. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

  • This product may produce surface staining of the teeth. Adequate toothbrushing may prevent these stains which are not harmful or permanent and may be removed by your dentist.

  • This is a fluoride preventive treatment gel, not a toothpaste. Read directions carefully before using.

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 or www.keystoneind.com

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GELATO HOMECARE 
stannous fluoride gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68400-201
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:68400-201-04120 g in 1 TUBE; Type 0: Not a Combination Product09/01/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35501/05/2013
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(68400-201) , label(68400-201)

Revised: 1/2022
Document Id: d6094e54-f558-efa4-e053-2995a90a273e
Set id: 1e93d4f8-1eec-40f8-8a6d-86e96dfeb8db
Version: 6
Effective Time: 20220120
 
Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.