Active Ingredient
Stannous Fluoride 0.4%
Gelato Homecare Gel
FDA Label NDC 68400-201
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Mycone Dental Supply Co., Inc Dba Keystone Industries And Deepak Products Inc. for the product Gelato Homecare (NDC 68400-201). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, otc - keep out of reach of children, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
- 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.
Otc - Keep Out Of Reach Of Children
- 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.
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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