NAFRINSE PACKETSKIT Bubble Gum

Manufacturer
Young Dental Manufacturing I, LLC | Medical Products Laboratories, Inc
Effective date
2018-12-13
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 20:26:58

Label at a glance#

ProductNAFRINSE PACKETSKIT Bubble Gum
Active ingredientSodium Fluoride
Label structure4 sections

Dosage and administration

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.

Label contents#

Full prescribing information#

Inactives  

INACTIVE INGREDIENT SECTION

Saccharin Sodium, Potassium Sorbate, Citric Acid, Flavoring

Dye

Warning:

WARNINGS SECTION

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

DOSAGE & ADMINISTRATION SECTION

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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

mintmintimage descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
851204NaFrinse 0.2 % Oral RinsePSN2
562510sodium fluoride 0.2 % Oral RinsePSN2
851204sodium fluoride 2 MG/ML Mouthwash [Nafrinse]SBD2
562510sodium fluoride 2 MG/ML MouthwashSCD2
851204Nafrinse 0.2 % MouthwashSY2
851204Nafrinse 2 MG/ML MouthwashSY2
562510sodium fluoride 0.2 % MouthwashSY2

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0273-8008-01NAFRINSE PACKETSKIT Bubble Gum3 g in 1 PACKETPOWDER32
0273-8008-02NAFRINSE PACKETSKIT Bubble Gum20 in 1 KITPOWDER202

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0273-8008NAFRINSE PACKETSKIT BUBBLE GUM (SODIUM FLUORIDE) POWDER [YOUNG DENTAL MANUFACTURING I, LLC]2Legacy NDC, 2 package rows20181215_4ca4be4a-6590-465f-be63-ee50bd421748.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0273-80080273-8008-01, 0273-8008-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
4d09eaa9-531c-47d9-83f5-c4286cff99df4ca4be4a-6590-465f-be63-ee50bd4217482018-12-13WarningsExact identifier
spl id: 4d09eaa9-531c-47d9-83f5-c4286cff99df
spl set id: 4ca4be4a-6590-465f-be63-ee50bd421748

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.