Therabreath Healthy Gums Oral Rinse

Therabreath Healthy Gums Oral Rinse
SPL v12
SPL
SPL Set ID 8f79bf5c-bbab-405a-8438-1fbb7769aec0
Route
ORAL
Published
Effective Date 2020-12-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Cetylpyridinium (0.0005 g)
Inactive Ingredients
Poloxamer 407 Water Sucralose Glycerin

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-12-01 Until 2022-01-31
Description

Cetylpyridinium chloride 0.05%

Purpose

Antigingivitis/Antiplaque

Medication Information

Purpose

Antigingivitis/Antiplaque

Description

Cetylpyridinium chloride 0.05%

Uses

•Helps prevent gingivitis, an early form of gum disease and bleeding gum

•Helps control plaque that leads to gingivitis and bleeding gums

Section 51945-4

72551-247-01

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.

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.

Active Ingredient

Cetylpyridinium chloride 0.05%

Other Information

This rinse is not intended to replace brushing or flossing.

Inactive Ingredients

Water, Glycerin, Poloxamer 407, Flavor, Sucralose

Therabreath Healthy Gums Oral Rinse

72551-247-05

Structured Label Content

Uses

•Helps prevent gingivitis, an early form of gum disease and bleeding gum

•Helps control plaque that leads to gingivitis and bleeding gums

Section 51945-4 (51945-4)

72551-247-01

Purpose

Antigingivitis/Antiplaque

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.

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.

Active Ingredient

Cetylpyridinium chloride 0.05%

Other Information

This rinse is not intended to replace brushing or flossing.

Inactive Ingredients

Water, Glycerin, Poloxamer 407, Flavor, Sucralose

Therabreath Healthy Gums Oral Rinse (TheraBreath Healthy Gums Oral Rinse)

72551-247-05

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:00:04.252257 · Updated: 2026-03-14T23:00:23.363901