GELATO HOMECARE- stannous fluoride gel

Gelato Homecare by

Drug Labeling and Warnings

Gelato Homecare by is a Otc medication manufactured, distributed, or labeled by Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

GELATO HOMECARE 
stannous fluoride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68400-201
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
STANNOUS FLUORIDE (UNII: 3FTR44B32Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.116 g  in 120 g

Inactive Ingredients
Ingredient Name	Strength
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
Color	white (Cloudy)	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68400-201-04	120 g in 1 TUBE; Type 0: Not a Combination Product	09/01/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	01/05/2013

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
Name	Address	ID/FEI	Business Operations
Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.		014769301	manufacture(68400-201) , label(68400-201)