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

Purpose

Antigingivitis/Antiplaque

Description

Cetylpyridinium chloride 0.05%


Medication Information

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.

Uses

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

•Helps control plaque that leads to gingivitis and bleeding gums

Purpose

Antigingivitis/Antiplaque

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, Glycerin, Poloxamer 407, Flavor, Sucralose

Description

Cetylpyridinium chloride 0.05%

Section 51945-4

72551-247-01

Active Ingredient

Cetylpyridinium chloride 0.05%

Therabreath Healthy Gums Oral Rinse

72551-247-05


Structured Label Content

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.

Uses

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

•Helps control plaque that leads to gingivitis and bleeding gums

Purpose

Antigingivitis/Antiplaque

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, Glycerin, Poloxamer 407, Flavor, Sucralose

Section 51945-4 (51945-4)

72551-247-01

Active Ingredient

Cetylpyridinium chloride 0.05%

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

72551-247-05


Advanced Ingredient Data


Raw Label Data

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