PERIOTHERAPY HEALTHY GUMS- sodium fluoride paste, dentifrice
Dr. Harold Katz, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

PerioTherapy Healthy Gums

Active Ingredient

Sodium fluoride 0.24%

(0.14% W/V fluoride ion)

Purpose

Anticavity Fluoride Dentrifice

Uses

Aids in the prevention of dental cavities

Warnings

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

Warnings

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

Directions

Other 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

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

PerioTherapy Healthy Gums Toothpaste

PERIOTHERAPY HEALTHY GUMS
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:72551-253
Route of Administration	DENTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.0024 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
XYLITOL (UNII: VCQ006KQ1E)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)
POTASSIUM PYROPHOSPHATE (UNII: B9W4019H5G)
ZINC GLUCONATE (UNII: U6WSN5SQ1Z)
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)
SODIUM CHLORITE (UNII: G538EBV4VF)
MENTHA PIPERITA (UNII: 79M2M2UDA9)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
SODIUM BENZOATE (UNII: OJ245FE5EU)
UBIDECARENONE (UNII: EJ27X76M46)

Product Characteristics
Color	white (Clear)	Score
Shape		Size
Flavor	MINT (Clean Mint)	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:72551-253-01	100 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/01/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part355	10/01/2018

Labeler - Dr. Harold Katz, LLC (965507767)