Label: GELATO HOMECARE- stannous fluoride gel

  • NDC Code(s): 68400-201-04
  • Packager: Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.
  • Category: HUMAN OTC DRUG LABEL

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.

Drug Label Information

Updated January 20, 2022

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  • Active Ingredient

    Stannous Fluoride 0.4%

  • Purpose

    Fluoride preventive treatment gel

  • Uses

    • Home Care is a stable fluoride gel for home use.
    • Aids in the prevention of dental decay.
  • WARNINGS

    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

  • PRINCIPAL DISPLAY PANEL

    BX.Gelato HC Stannous_generic.jpg

  • PRINCIPAL DISPLAY PANEL

    SC.Gelato HC Stannous_generic.jpg

  • INGREDIENTS AND APPEARANCE
    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)