Therabreath ™

Therabreath ™
SPL v8
SPL
SPL Set ID e06bfc9e-38e5-475b-89c1-026ccfe56031
Route
ORAL
Published
Effective Date 2023-08-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Cetylpyridinium (0.01 mg)
Inactive Ingredients
Water Glycerin Poloxamer 407 Sucralose

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-02-13

Description

Drug Facts

Purpose

Antigingivitis/Antiplaque


Medication Information

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.
Other Information

This rinse is not intended to replace brushing or flossing.

Active Ingredients

Cetylpyridinium Chloride 0.05%

Inactive Ingredients

Water, Glycerin, Poloxamer 407, Flavor, 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

ANTIGINGIVITIS/ ANTIPLAQUE MOUTHRINSE

SAVE!

VALUE

SIZE

TheraBreath

DENTIST FORMULATED

HEALTHY GUMS

ORAL RINSE

HELPS FIGHT GINGIVITIS FOR 24 HOURS*

HELPS REDUCE PLAQUE THAT LEADS TO GUM DISEASE

Reduces Occurrence of Bleeding Gums • Freshens Breath

No Alcohol • No Dyes • Non Burning

CLEAN MINT

33.8 fl. oz.

1 liter


Structured Label Content

Uses
  • Helps prevent • gingivitis, an early form of gum disease • bleeding gums
  • Helps control plaque that leads to • gingivitis • 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 0.05%

Inactive Ingredients

Water, Glycerin, Poloxamer 407, Flavor, 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)

ANTIGINGIVITIS/ ANTIPLAQUE MOUTHRINSE

SAVE!

VALUE

SIZE

TheraBreath

DENTIST FORMULATED

HEALTHY GUMS

ORAL RINSE

HELPS FIGHT GINGIVITIS FOR 24 HOURS*

HELPS REDUCE PLAQUE THAT LEADS TO GUM DISEASE

Reduces Occurrence of Bleeding Gums • Freshens Breath

No Alcohol • No Dyes • Non Burning

CLEAN MINT

33.8 fl. oz.

1 liter


Advanced Ingredient Data


Raw Label Data

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