MedPath

Gelato Perio Maintenance Rinse

Approved
Approval ID

d2f0df92-d52f-4c9c-99d0-3cd2a025e5e9

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 20, 2022

Manufacturers
FDA

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
NDC Product Code68400-202
Product Classification
G
Generic Name
Stannous Fluoride
Product Specifications
Route of AdministrationDENTAL
Effective DateJanuary 20, 2022
FDA Product Classification

INGREDIENTS (5)

GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
STANNOUS FLUORIDEActive
Quantity: 0.34 g in 283.5 g
Code: 3FTR44B32Q
Classification: ACTIM

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 1/16/2019

LB.Perio Rinses_generic.jpg

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 1/16/2019

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

LOINC: 42229-5Updated: 1/16/2019

Purpose:

Anticavity, antigingivitis, antihypersensitivity mouthrinse

WARNINGS SECTION

LOINC: 34071-1Updated: 1/16/2019

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

LOINC: 59845-8Updated: 1/16/2019

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

LOINC: 51727-6Updated: 1/16/2019

Inactive Ingredients:

Flavor, Glycerin, Methyl Paraben, Propyl Paraben and Sodium Saccharin.

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 1/16/2019

Other Information:

Store at controlled room temperature 59° - 86°F (15°-30°C). Protect from freezing.

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Gelato Perio Maintenance Rinse - FDA Drug Approval Details