NAFRINSE PACKETSKIT BUBBLE GUM- sodium fluoride powder

NAFRINSE PACKETSKIT Bubble Gum by

Drug Labeling and Warnings

NAFRINSE PACKETSKIT Bubble Gum by is a Prescription medication manufactured, distributed, or labeled by Young Dental Manufacturing I, LLC, Medical Products Laboratories, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Inactives  

Saccharin Sodium, Potassium Sorbate, Citric Acid, Flavoring

Dye

Warning:

This Packet contains sodium fluoride powder, contents poisonous if swallowed. keep away from children. Store in a dry place at controlled room temperature. For professional use only.

DO NOT SWALLOW

MISSUSE If child swallows dispensed amount of mouth rinse in a cup:

1. Do not panic -this amount should not hurt the child

2. In rare cases the child may feel slightly nauseous.

The child may have a serving of milk or ice cream to relieve the nausea. EMERGENCY TREATMENT If a child swallows more than one dispensed amount in a cup or powder contents of the fluoride mouth rinse packet call the Poison Control Center at 800-222-1222

Directions

Mix contents with stated amount of tap water until dissolved (read directions on jug label) Makes an 0.2 % solution of sodium fluoride mouthrinse aftert dilution. Swish 10 ml (2 teaspoons) around vigorously in the mouth for one minute and then spit out. To be used once a week.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

NAFRINSE PACKETSKIT BUBBLE GUM 
sodium fluoride powder

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 0273-8008
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O)	Fluoride Ion	1 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
Potassium Sorbate (UNII: 1VPU26JZZ4)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)

Product Characteristics
Color		Score
Shape		Size
Flavor	BUBBLE GUM (bubble gum)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0273-8008-02	20 in 1 KIT	09/25/2017
1	NDC: 0273-8008-01	3 g in 1 PACKET; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		09/25/2017

Labeler - Young Dental Manufacturing I, LLC (006309355)

Registrant - Young Dental Manufacturing I, LLC (006309355)

Establishment
Name	Address	ID/FEI	Business Operations
Medical Products Laboratories, Inc		002290302	manufacture(0273-8008)