FDA.reportPublic FDA data

PerioTherapy Healthy Gums

Manufacturer
Dr. Harold Katz, LLC
Effective date
2021-02-10
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:37:59

Label at a glance#

ProductPerioTherapy Healthy Gums
Active ingredientSODIUM FLUORIDE
Label structure8 sections

Indications and uses

Aids in the prevention of dental cavities

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium fluoride 0.24%

(0.14% W/V fluoride ion)

Purpose

OTC - PURPOSE SECTION

Anticavity Fluoride Dentrifice

Uses

INDICATIONS & USAGE SECTION

Aids in the prevention of dental cavities

Warnings

WARNINGS SECTION

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

Warnings

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children under 6 years of age.

Other information

OTHER SAFETY INFORMATION

  • If spilled on fabrics, wash out immediately.
  • This product was sealed with protective packaging at

the laboratory.
• If seal is missing, do not use.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water (Aqua), Hydrated Silica, Sorbitol, Glycerin, Tetrapotassium Pyrophosphate, Tetrasodium Pyrophosphate, Xylitol, Sodium Lauroyl Sarcosinate, Sodium Chlorite (PeriO2), Mentha Piperita (Peppermint) Oil, Zinc Gluconate (ZincRx), Aloe Barbadensis Leaf Juice, Sodium Benzoate, Ubiquinone.

TheraBreath Perio Therapy Healthy Gums Toothpaste

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PerioTherapy Healthy Gums ToothpastePerioTherapy Healthy Gums Toothpaste

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
416783sodium fluoride 0.24 % ToothpastePSN3
416783sodium fluoride 0.0024 MG/MG ToothpasteSCD3
416783sodium fluoride 0.24 % (fluoride ion 0.13 % ) ToothpasteSY3
416783sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSY3
416783sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72551-253-012023-01-30C16284748780-1ba0f9c33-2e8f-a910-e053-dadaa90a0b85PerioTherapy Healthy Gums
72551-253-012021-02-10C16284748780-1ba0f9c33-2e8f-a910-e053-dadaa90a0b85PerioTherapy Healthy Gums
72551-253-012021-01-29C16284748780-1ba0f9c33-2e8f-a910-e053-dadaa90a0b85PerioTherapy Healthy Gums

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72551-253-01PerioTherapy Healthy Gums100 g in 1 BOTTLE, PLASTICPASTE, DENTIFRICE1003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72551-253PERIOTHERAPY HEALTHY GUMS (SODIUM FLUORIDE) PASTE, DENTIFRICE [DR. HAROLD KATZ, LLC]3Legacy NDC, 1 package rows20210211_7f34abc2-af6d-0bb2-e053-2991aa0a04ab.zip

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72551-25372551-253-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
SORBITOL506T60A25RIACT
XYLITOLVCQ006KQ1EIACT
HYDRATED SILICAY6O7T4G8P9IACT
GLYCERINPDC6A3C0OXIACT
SODIUM LAUROYL SARCOSINATE632GS99618IACT
POTASSIUM PYROPHOSPHATEB9W4019H5GIACT
ZINC GLUCONATEU6WSN5SQ1ZIACT
SODIUM PYROPHOSPHATEO352864B8ZIACT
SODIUM CHLORITEG538EBV4VFIACT
SODIUM FLUORIDE8ZYQ1474W7ACTIM
MENTHA PIPERITA79M2M2UDA9IACT
ALOE VERA LEAFZY81Z83H0XIACT
SODIUM BENZOATEOJ245FE5EUIACT
UBIDECARENONEEJ27X76M46IACT

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
bafe7895-63ff-2ec3-e053-2995a90a43467f34abc2-af6d-0bb2-e053-2991aa0a04ab2021-02-10WarningsExact identifier
spl id: bafe7895-63ff-2ec3-e053-2995a90a4346
spl set id: 7f34abc2-af6d-0bb2-e053-2991aa0a04ab

Reported adverse events (FAERS/openFDA)#

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