NAFRINSE PACKETSKIT VERY BERRY

NAFRINSE PACKETSKIT VERY BERRY- sodium fluoride powder
Young Dental Manufacturing Co 1, LLC.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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.

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NAFRINSE PACKETSKIT VERY BERRY
sodium fluoride powder
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0273-8010
Route of Administration DENTAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Sodium Fluoride (Fluoride Ion) Fluoride Ion 1 g in 1 g
Inactive Ingredients
Ingredient Name Strength
SACCHARIN SODIUM
Potassium Sorbate
ANHYDROUS CITRIC ACID
Product Characteristics
Color Score
Shape Size
Flavor BERRY (very berry) Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0273-8010-02 20 PACKET in 1 KIT contains a PACKET (0273-8010-01)
1 NDC:0273-8010-01 3 g in 1 PACKET This package is contained within the KIT (0273-8010-02)
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 Co 1, LLC. (006309355)
Registrant — Medical Products Laboratories, Inc (002290302)
Establishment
Name Address ID/FEI Operations
Medical Products Laboratories, Inc 002290302 manufacture (0273-8010)

Revised: 12/2018 Young Dental Manufacturing Co 1, LLC.

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