THERABREATH HEALTHY GUMS ORAL RINSE- cetylpyridinium chloride rinse

TheraBreath Healthy Gums Oral Rinse by

Drug Labeling and Warnings

TheraBreath Healthy Gums Oral Rinse by is a Otc medication manufactured, distributed, or labeled by Dr. Harold Katz, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Cetylpyridinium chloride 0.05%

Purpose

Antigingivitis/Antiplaque

Uses

Helps prevent gingivitis, an early form of gum disease and bleeding gum
Helps control plaque that leads to gingivitis and bleeding gums

Warnings

Keep out of reach of children under 6 years of age. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Warnings

Stop Use and Ask a Doctor If

• Gingivitis, bleeding, or redness persists for more than 2 weeks.
• You have painful or swollen gums, pus from the gum line, loose teeth, or increasing spacing between teeth. These may or symptoms of periodontitis, a serious form of gum disease.

Directions

• Adults and Children 12 years and older:

  Vigorously swish 20 milliliters (4 teaspoonfuls) of rinse between your teeth

  twice a day for 30 seconds and then spit out. Do not swallow the rinse.

• Children 6 years to under12 years: supervise use.
• Children under 6 years: Do not use.

Other Information

This rinse is not intended to replace brushing or flossing.

Inactive Ingredients

Water, Sorbitol, Xylitol, PEG-40 Hydrogenated Castor Oil, Flavor, Citric Acid, Sodium Hydroxide, Sodium Bicarbonate,

Zinc Gluconate, Sodium Chlorite, Sodium Citrate

TheraBreath Healthy Gums Oral Rinse

Healthy Gums Rinse Travel Size

Healthy Gums Travel Pouch 0.25 oz

INGREDIENTS AND APPEARANCE

THERABREATH HEALTHY GUMS ORAL RINSE 
cetylpyridinium chloride rinse

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72551-247
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3)	CETYLPYRIDINIUM CHLORIDE	0.0005 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
XYLITOL (UNII: VCQ006KQ1E)
PEG-40 CASTOR OIL (UNII: 4ERD2076EF)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
ZINC GLUCONATE (UNII: U6WSN5SQ1Z)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SODIUM CHLORITE (UNII: G538EBV4VF)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72551-247-01	473 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/01/2019
2	NDC: 72551-247-02	85.05 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/19/2018
3	NDC: 72551-247-03	7 g in 1 POUCH; Type 0: Not a Combination Product	03/19/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	10/02/2018

Labeler - Dr. Harold Katz, LLC (965507767)