Gelato Perio Maintenance Rinse
d2f0df92-d52f-4c9c-99d0-3cd2a025e5e9
HUMAN PRESCRIPTION DRUG LABEL
Jan 20, 2022
Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.
DUNS: 014769301
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Stannous Fluoride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (5)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
INDICATIONS & USAGE SECTION
Indications and Usage:
Aids in the prevention of dental decay. Helps prevent gingivitis. Helps control plaque bacteria. Increases protection against painful tooth sensitivity. This product mist be used under the supervision of a dentist.
SPL UNCLASSIFIED SECTION
Purpose:
Anticavity, antigingivitis, antihypersensitivity mouthrinse
WARNINGS SECTION
Warnings:
- Keep out of reach of children.
- Do not swallow. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
- Do not use until diluted.
- This product may produce surface staining of the teeth.
- This product may produce surface staining of the teeth. Adequate tooth-brushing may prevent these stains which are not harmful or permanent and may be removed by your dentist.
INSTRUCTIONS FOR USE SECTION
Directions:
Adults and children 6 years of age and older:
- Do not use before mixing with water. Use immediately after preparing the rinse.
- Shake concentrate well before mixing with water.
- Remove cap and replace with pump.
- Rotate spout counter 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.
**Children under 6 years of age:**Consult a dentist or doctor.
INACTIVE INGREDIENT SECTION
Inactive Ingredients:
Flavor, Glycerin, Methyl Paraben, Propyl Paraben and Sodium Saccharin.
STORAGE AND HANDLING SECTION
Other Information:
Store at controlled room temperature 59° - 86°F (15°-30°C). Protect from freezing.