NAFRINSE UNIT DOSE VERRY BERRY

Manufacturer
Young Dental Manufacturing Co 1, LLC. | Medical Products Laboratories, Inc
Effective date
2018-12-14
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 20:26:58

Label at a glance#

ProductNAFRINSE UNIT DOSE MINT FLAVOR
Active ingredientSodium Fluoride
Label structure7 sections

Dosage and administration

DIRECTIONS FOR USE: {Best Results • Use Early Morning) 1. Each pupil receives one cup and one napkin. 2. Have the pupils remove the lids from the cups. 3. Have the pupils empty the contents of the cup into their mouths and swish thoroughly for one minute. 4. HOLD CUP AGAINST THE MOUTH. Spit solution back into the cup. 5. Have the pupils wipe their mouths with the napkin; then stuff the napkin slowly into the cup t...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Sodium Fluoride

Inactives  

INACTIVE INGREDIENT SECTION

Saccharin Sodium, Potassium Sorbate, Citric Acid, Flavoring

Dye ( Only present in Mint and Very Berry flavors)

Purpose

OTC - PURPOSE SECTION

Prevention of dental caries.

Warning:

WARNINGS SECTION

a) Do not swallow b) Do not eat, drink or rinse with water for 30 minutes after use. c) Instruct children under 12 years of age in the use of the product and in good brushing and rinsing habits to minimize swallowing d) Not recommended for use in children younger than 6 years of age.

Dosage and Administration:

DOSAGE & ADMINISTRATION SECTION

DIRECTIONS FOR USE: {Best Results • Use Early Morning)

1. Each pupil receives one cup and one napkin. 2. Have the pupils remove the lids from the cups. 3. Have the pupils empty the contents of the cup into their mouths and swish thoroughly for one minute. 4. HOLD CUP AGAINST THE MOUTH. Spit solution back into the cup. 5. Have the pupils wipe their mouths with the napkin; then stuff the napkin slowly into the cup to absorb the solution. 6. Discard the cup with the napkin into the provided trash bag. a) Do not swallow b) Do not eat, drink or rinse with water for 30 minutes after use. c) Instruct children under 12 years of age in the use of the product and in good brushing and rinsing habits to minimize swallowing d) Not recommended for use in children younger than 6 years of age. ADDITIONAL INSTRUCTIONS/IMPORTANT: In order to avoid spillage of the solution from the cup, the children must be instructed to do the following: 1) When spitting the fluoride solution from the mouth back into the cup, the children must hold the cup close to the mouth, and spit slowly into the cup. 2) The napkins must be stuffed into the cups very slowly in order to avoid spillage.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bubble 5Bubble 5Bubble 10Bubble 10

MintMintVery BerryVery Berry

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
0273-8002-01NAFRINSE UNIT DOSE MINT FLAVOR10 mL in 1 CUPSOLUTION102
0273-8003-01NAFRINSE UNIT DOSE BUBBLE GUM10 mL in 1 CUPSOLUTION102
0273-8004-01NAFRINSE UNIT DOSE BUBBLE GUM5 mL in 1 CUPSOLUTION52
0273-8005-01NAFRINSE UNIT DOSE VERRY BERRY10 mL in 1 CUPSOLUTION102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0273-8002NAFRINSE UNIT DOSE MINT FLAVOR (SODIUM FLUORIDE AND HYDROFLUORIC ACID) SOLUTION NAFRINSE UNIT DOSE BUBBLE GUM (SODIUM FLUORIDE AND HYDROFLUORIC ACID) SOLUTION NAFRINSE UNIT DOSE VERRY BERRY (SODIUM FLUORIDE AND HYDROFLUORIC ACID) SOLUTION [YOUNG DENTAL MANUFACTURING CO 1, LLC.]2Legacy NDC, 1 package rows20181215_757f1c48-f4ed-4021-a08b-f29bbeec74ff.zip
0273-8003NAFRINSE UNIT DOSE MINT FLAVOR (SODIUM FLUORIDE AND HYDROFLUORIC ACID) SOLUTION NAFRINSE UNIT DOSE BUBBLE GUM (SODIUM FLUORIDE AND HYDROFLUORIC ACID) SOLUTION NAFRINSE UNIT DOSE VERRY BERRY (SODIUM FLUORIDE AND HYDROFLUORIC ACID) SOLUTION [YOUNG DENTAL MANUFACTURING CO 1, LLC.]2Legacy NDC, 1 package rows20181215_757f1c48-f4ed-4021-a08b-f29bbeec74ff.zip
0273-8004NAFRINSE UNIT DOSE MINT FLAVOR (SODIUM FLUORIDE AND HYDROFLUORIC ACID) SOLUTION NAFRINSE UNIT DOSE BUBBLE GUM (SODIUM FLUORIDE AND HYDROFLUORIC ACID) SOLUTION NAFRINSE UNIT DOSE VERRY BERRY (SODIUM FLUORIDE AND HYDROFLUORIC ACID) SOLUTION [YOUNG DENTAL MANUFACTURING CO 1, LLC.]2Legacy NDC, 1 package rows20181215_757f1c48-f4ed-4021-a08b-f29bbeec74ff.zip
0273-8005NAFRINSE UNIT DOSE MINT FLAVOR (SODIUM FLUORIDE AND HYDROFLUORIC ACID) SOLUTION NAFRINSE UNIT DOSE BUBBLE GUM (SODIUM FLUORIDE AND HYDROFLUORIC ACID) SOLUTION NAFRINSE UNIT DOSE VERRY BERRY (SODIUM FLUORIDE AND HYDROFLUORIC ACID) SOLUTION [YOUNG DENTAL MANUFACTURING CO 1, LLC.]2Legacy NDC, 1 package rows20181215_757f1c48-f4ed-4021-a08b-f29bbeec74ff.zip

Products#

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NDC Codes#

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 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
91d550c5-993f-4059-b369-c4401dfc80f2757f1c48-f4ed-4021-a08b-f29bbeec74ff2018-12-14WarningsExact identifier
spl id: 91d550c5-993f-4059-b369-c4401dfc80f2
spl set id: 757f1c48-f4ed-4021-a08b-f29bbeec74ff

Reported adverse events (FAERS/openFDA)#

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