Therabreath ™

Therabreath ™
SPL v4
SPL
SPL Set ID 4987c71b-334d-4b20-bab4-b857e08a7383
Route
ORAL
Published
Effective Date 2025-12-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Cetylpyridinium (0.015 mg)
Inactive Ingredients
Water Glycerin Poloxamer 407 Sodium Benzoate Sucralose

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-04-25

Description

Drug Facts

Purpose

Antigingivitis/Antiplaque


Medication Information

Warnings and Precautions

Warnings

Purpose

Antigingivitis/Antiplaque

Description

Drug Facts

Uses
  • helps prevent • gingivitis, an early form of gum disease • bleeding gums
  • helps control plaque that leads to • gingivitis • 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.
Active Ingredient

Cetylpyridinium Chloride 0.075%

Other Information
  • this rinse is not intended to replace brushing or flossing
Inactive Ingredients

water, glycerin, poloxamer 407, flavor, sodium benzoate, sucralose

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

USE BEFORE BRUSHING

ANTIGINGIVITIS/ANTIPLAQUE MOUTHRINSE

TheraBreath

DENTIST FORMULATED

PLAQUE CONTROL

PRE-BRUSH

ORAL RINSE

HELPS FIGHT PLAQUE & GINGIVITIS FOR 12 HOURS*

Helps reduce gingivitis, an early form of gum disease

ANTI-BACTERIAL RINSE • CLEANS WHOLE MOUTH

No Alcohol • No Dyes • Non Burning

REFRESHING MINT

16 fl. oz.

473 mL

*As part of an oral care routine.


Structured Label Content

Uses
  • helps prevent • gingivitis, an early form of gum disease • bleeding gums
  • helps control plaque that leads to • gingivitis • bleeding gums
Warnings and Precautions (34071-1)

Warnings

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.
Active Ingredient

Cetylpyridinium Chloride 0.075%

Other Information (Other information)
  • this rinse is not intended to replace brushing or flossing
Inactive Ingredients

water, glycerin, poloxamer 407, flavor, sodium benzoate, sucralose

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)

USE BEFORE BRUSHING

ANTIGINGIVITIS/ANTIPLAQUE MOUTHRINSE

TheraBreath

DENTIST FORMULATED

PLAQUE CONTROL

PRE-BRUSH

ORAL RINSE

HELPS FIGHT PLAQUE & GINGIVITIS FOR 12 HOURS*

Helps reduce gingivitis, an early form of gum disease

ANTI-BACTERIAL RINSE • CLEANS WHOLE MOUTH

No Alcohol • No Dyes • Non Burning

REFRESHING MINT

16 fl. oz.

473 mL

*As part of an oral care routine.


Advanced Ingredient Data


Raw Label Data

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