NAFRINSE PACKETS BUBBLE GUM- 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.

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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.

image description

NAFRINSE PACKETS BUBBLE GUM 
sodium fluoride powder
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0273-8018
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O) Fluoride Ion1 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
Potassium Sorbate (UNII: 1VPU26JZZ4)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
Product Characteristics
Color    Score    
ShapeSize
FlavorBUBBLE GUM (bubble gum) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0273-8018-0350 in 1 PACKAGE09/21/2017
13 g in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other09/21/2017
Labeler - Young Dental Manufacturing Co 1, LLC. (006309355)
Registrant - Young Dental Manufacturing Co 1, LLC. (006309355)
Establishment
NameAddressID/FEIBusiness Operations
Medical Products Laboratories, Inc.002290302manufacture(0273-8018)

Revised: 12/2018
Document Id: d76f0d13-9816-48b8-acf0-84a2ea8832ef
Set id: aad48471-28d5-46f2-800a-c76ccb4d8d7f
Version: 2
Effective Time: 20181213
 
Young Dental Manufacturing Co 1, LLC.