Drugplain

Gelato Homecare .116 g/120g

Stannous Fluoride · GEL · Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.

No Recall History
Plain English

Gelato Homecare is an over-the-counter dental gel containing stannous fluoride that helps prevent tooth decay and strengthen tooth enamel. You apply it directly to your teeth as part of your daily oral hygiene routine.

Key Facts

Brand Name
Gelato Homecare
Generic Name
Stannous Fluoride
NDC Code (Product)
68400-201
Manufacturer
Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.
Strength
.116 g/120g
Dosage Form
GEL
Route
DENTAL
Marketing Status
Application #
M021
Marketing Start
01/05/2013

Recall History

No Recall History

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

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

Dosage & Administration

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.

Warnings

Warnings 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.

Frequently Asked Questions

What is Gelato Homecare used for?

Gelato Homecare is an over-the-counter dental gel containing stannous fluoride that helps prevent tooth decay and strengthen tooth enamel. You apply it directly to your teeth as part of your daily oral hygiene routine.

Is Gelato Homecare a controlled substance?

Gelato Homecare is not classified as a controlled substance by the DEA.

What is the generic name for Gelato Homecare?

The generic name for Gelato Homecare is Stannous Fluoride. There are 12 other brand versions of Stannous Fluoride.

What is the NDC code for Gelato Homecare .116 g/120g?

The NDC (National Drug Code) for Gelato Homecare .116 g/120g is 68400-201, listed by Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc..