FDA Label for Gelato Perio Maintenance Rinse
View Indications, Usage & Precautions
Gelato Perio Maintenance Rinse Product Label
The following document was submitted to the FDA by the labeler of this product Mycone Dental Supply Co., Inc Dba Keystone Industries And Deepak Products Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient:
Stannous Fluoride 0.63% Concentrate (0.12% w/v fluoride ion).
Directions:
Adults and children 6 years of age and older:
- Do not use before mixing with water. Use immediately after preparing the rinse.
- Remove cap and replace with pump.
- Rotate spout container clockwise to extend.
- Depress pump until rinse comes to the tip of the pump.
- Depress pump twice into cup provided (1/8oz). Add water to line (1oz) on cup. Mix well.
- Vigorously swish rinse between your teeth for 1 minute and then spit out. Do not swallow the rinse. Do not eat or drink for 30 minutes after rinsing.
- 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.
- Consult a dentist or doctor.
Children under 6 years of age:
Inactive Ingredients:
Flavor, Glycerin, Methyl paraben, Propyl paraben and Sodium Saccharin.
Other Information:
Store at controlled room temperature 59° - 86°F (15°-30°C). Protect from freezing.
Package Label.Principal Display Panel
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