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Gelato Homecare by Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.

Medically reviewed on November 20, 2017

Dosage form: gel
Ingredients: Stannous Fluoride 0.116g in 120g
Labeler: Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.
NDC Code: 68400-205

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.

Active Ingredient:

Stannous Fluoride 0.4%

Purpose:

Fluoride preventive treatment gel.

Uses
  • Home Care is a stable, water-free fluoride gel for home use.
  • Aids in the prevention of dental decay.

Keep out of reach of children.

Warnings
  • 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 and 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.

GELATO HOMECARE 
stannous fluoride gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68400-205
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Stannous Fluoride (Fluoride Ion) Fluoride Ion0.116 g  in 120 g
Inactive Ingredients
Ingredient NameStrength
GLYCERIN 
Water  
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) 
CARBOXYMETHYLCELLULOSE SODIUM 
Malic Acid 
Xanthan Gum 
Product Characteristics
Colorwhite (Cloudy) Score    
ShapeSize
FlavorBERRY (Red Berry) Imprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:68400-205-04120 g in 1 TUBE
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. (078654194)
Registrant - Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. (014769301)
Establishment
NameAddressID/FEIOperations
Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.078654194manufacture(68400-205), label(68400-205)

 
Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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