Therabreath ™

Therabreath ™
SPL v3
SPL
SPL Set ID 19bb1bc2-f4e3-4faa-82a5-656fec4397dd
Route
ORAL
Published
Effective Date 2023-12-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Cetylpyridinium (20 mg)
Inactive Ingredients
Water Glycerin Poloxamer 407 Sucralose

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-06-30

Description

Drug Facts

Purpose

Antigingivitis/Antiplaque


Medication Information

Purpose

Antigingivitis/Antiplaque

Description

Drug Facts

Uses
  • Helps prevent gingivitis, an early form of gum disease and bleeding gums
  • Helps control plaque that leads to gingivitis and bleeding gums
Section 42229-5

Drug Facts

Section 50565-1

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 under 12 years Supervise use.
Children under 6 years Do not use.
Other Information

This rinse is not intended to replace brushing or flossing.

Active Ingredients

Cetylpyridinium Chloride 0.1%

Inactive Ingredients

Flavor, Glycerin, Poloxamer 407, Sucralose, Water

Stop Use and Ask A Dentist 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 be signs or symptoms of periodontitis, a serious form of gum disease.
Principal Display Panel 473 Ml Bottle Label

ALCOHOL

FREE

ANTIGINGIVITIS/ANTIPLAQUE MOUTHRINSE

TheraBreath

DENTIST FORMULATED

DEEP CLEAN

ORAL RINSE

KILLS 99.9% OF GERMS

THAT CAUSE BAD BREATH, PLAQUE & GINGIVITIS*

ANTISEPTIC

No Alcohol • No Dyes • Non Burning

FRESH MINT

16 fl.oz.

473 mL


Structured Label Content

Uses
  • Helps prevent gingivitis, an early form of gum disease and bleeding gums
  • Helps control plaque that leads to gingivitis and bleeding gums
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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.

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 under 12 years Supervise use.
Children under 6 years Do not use.
Other Information (Other information)

This rinse is not intended to replace brushing or flossing.

Active Ingredients

Cetylpyridinium Chloride 0.1%

Inactive Ingredients

Flavor, Glycerin, Poloxamer 407, Sucralose, Water

Stop Use and Ask A Dentist If (Stop use and ask a dentist 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 be signs or symptoms of periodontitis, a serious form of gum disease.
Principal Display Panel 473 Ml Bottle Label (PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label)

ALCOHOL

FREE

ANTIGINGIVITIS/ANTIPLAQUE MOUTHRINSE

TheraBreath

DENTIST FORMULATED

DEEP CLEAN

ORAL RINSE

KILLS 99.9% OF GERMS

THAT CAUSE BAD BREATH, PLAQUE & GINGIVITIS*

ANTISEPTIC

No Alcohol • No Dyes • Non Burning

FRESH MINT

16 fl.oz.

473 mL


Advanced Ingredient Data


Raw Label Data

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