TheraBreath for Kids Anti Cavity Oral Rinse

Manufacturer
Dr. Harold Katz, LLC
Effective date
2022-02-03
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-05-31 23:47:56

Label at a glance#

ProductTheraBreath for Kids Anti Cavity Oral Rinse
Active ingredientSODIUM FLUORIDE
Label structure9 sections

Dosage and administration

• Adults and children 6 years of age and older: Use once a day after brushing your teeth with a toothpaste. Vigorously swish 10 milliliters of rinse between your teeth for 1 minute and then spit out. Do not swallow the rinse. • Do not eat or drink for 30 minutes after rinsing. • Instruct children under 12 years of age in good rinsing habits (to minimize swallowing). Supervise children as necessary until capable of...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium Fluoride 0.05% (0.02%) w/v fluoride ion)

Purpose

OTC - PURPOSE SECTION

Anticavity

Use

INDICATIONS & USAGE SECTION

Aids in the prevention of dental cavities

Warnings

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep Out Of Reach of Children.

Warnings

WARNINGS SECTION

If more than used for rinsing is accidentally swallowed, get help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

• Adults and children 6 years of age and older: Use once a day after brushing your teeth with a
toothpaste. Vigorously swish 10 milliliters of rinse between your teeth for 1 minute and then spit out. Do not

swallow the rinse.
• Do not eat or drink for 30 minutes after rinsing.
• Instruct children under 12 years of age in good rinsing habits (to minimize swallowing).
Supervise children as necessary until capable of using without supervision.
• Children under 6 years of age: Consult a dentist or doctor.

Other information

OTHER SAFETY INFORMATION

Do not use if safety seal is broken or missing

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Glycerin, Sodium Benzoate, Flavor (Organic), Xylitol, Citric Acid, Sucralose, Sodium Citrate

TheraBreath Kids Anti Cavity Oral Rinse

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Kids Anti Cavity Oral Rinse LabelKids Anti Cavity Oral Rinse Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
240698sodium fluoride 0.05 % (fluoride ion 0.02 % ) Oral RinsePSN7
240698sodium fluoride 0.5 MG/ML MouthwashSCD7
240698sodium fluoride 0.05 % (fluoride ion 0.02 % ) Oral RinseSY7

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72551-254-01TheraBreath for Kids Anti Cavity Oral Rinse473 g in 1 BOTTLE, PLASTICRINSE4737

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72551-254THERABREATH FOR KIDS ANTI CAVITY ORAL RINSE (SODIUM FLUORIDE) RINSE [DR. HAROLD KATZ, LLC]7Legacy NDC, 1 package rows20220204_7f34bc73-1940-07a7-e053-2a91aa0a1bfe.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72551-25472551-254-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 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
d7216ca6-f32b-c9e4-e053-2995a90a45d07f34bc73-1940-07a7-e053-2a91aa0a1bfe2022-02-03WarningsExact identifier
spl id: d7216ca6-f32b-c9e4-e053-2995a90a45d0
spl set id: 7f34bc73-1940-07a7-e053-2a91aa0a1bfe

Reported adverse events (FAERS/openFDA)#

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