Therabreath™ Deep Clean Dentist Formulated Toothpaste, Fresh Mint

Therabreath™ Deep Clean Dentist Formulated Toothpaste, Fresh Mint
SPL v1
SPL
SPL Set ID 3c372f26-e0c4-0659-e063-6294a90ae9f9
Route
ORAL
Published
Effective Date 2025-08-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.454 g)
Inactive Ingredients
Water Hydrated Silica Glycerin Pentasodium Triphosphate Peg-8 Silicon Dioxide Sucralose Titanium Dioxide Sodium Lauryl Sulfate Sodium Lauroyl Sarcosinate Xanthan Gum Crospovidone, Unspecified

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-08-01

Description

Drug Facts

Purpose

Anticavity/Antigingivitis


Medication Information

Warnings and Precautions

Warnings

Purpose

Anticavity/Antigingivitis

Description

Drug Facts

Uses

• aids in the prevention of dental decay • helps prevent • gingivitis, an early form of gum disease • bleeding gums • helps interfere with harmful effects of plaque associated with gingivitis

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children under 6 years of age.

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

• do not swallow • supervise children as necessary until capable of using without supervision

adults and children 2 years of age and older brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor
children under 6 years of age instruct in good brushing and rinsing habits (to minimize swallowing)
children under 2 years of age consult a dentist or doctor

Active Ingredient

Stannous fluoride 0.454% (0.14% w/v fluoride ion)

Inactive Ingredients

water, hydrated silica, glycerin, pentasodium triphosphate, PEG-8, silica, sodium lauryl sulfate, flavor, sodium lauroyl sarcosinate, polyvinylpyrrolidone, titanium dioxide, xanthan gum, sucralose

Questions Or Comments?

Therabreath™ is manufactured by

Church & Dwight Co., Inc., Ewing, NJ 02628 U.S.A.

Phone: 1-800-973-7374 WEB: WWW.THERABREATH.COM

Principal Display Panel

LONG LASTING FOR EPIC FRESHNESS

TheraBreath™

DEEP CLEAN

DENTIST FORMULATED TOOTHPASTE

Anticavity/Antigingivitus

KILLS 99.9% OF GERMS

THAT CAUSE BAD BREATH, PLAQUE, AND GINGIVITIS*

TWIN PACK *in laboratory tests

Neutralizes the source of bad breath*

*in laboratory tests

Gently whitens

Dr. Harold Katz

Fresh Mint

2 TUBES of 4.0 oz (113 g)

TOTAL NET WT. 8.0 oz (226 g)

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 the teeth. These may be signs or symptoms of periodontitis, a serious form of gum disease.


Structured Label Content

Uses

• aids in the prevention of dental decay • helps prevent • gingivitis, an early form of gum disease • bleeding gums • helps interfere with harmful effects of plaque associated with gingivitis

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 brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Purpose

Anticavity/Antigingivitis

Directions

• do not swallow • supervise children as necessary until capable of using without supervision

adults and children 2 years of age and older brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor
children under 6 years of age instruct in good brushing and rinsing habits (to minimize swallowing)
children under 2 years of age consult a dentist or doctor

Active Ingredient

Stannous fluoride 0.454% (0.14% w/v fluoride ion)

Inactive Ingredients

water, hydrated silica, glycerin, pentasodium triphosphate, PEG-8, silica, sodium lauryl sulfate, flavor, sodium lauroyl sarcosinate, polyvinylpyrrolidone, titanium dioxide, xanthan gum, sucralose

Questions Or Comments? (Questions or Comments?)

Therabreath™ is manufactured by

Church & Dwight Co., Inc., Ewing, NJ 02628 U.S.A.

Phone: 1-800-973-7374 WEB: WWW.THERABREATH.COM

Principal Display Panel

LONG LASTING FOR EPIC FRESHNESS

TheraBreath™

DEEP CLEAN

DENTIST FORMULATED TOOTHPASTE

Anticavity/Antigingivitus

KILLS 99.9% OF GERMS

THAT CAUSE BAD BREATH, PLAQUE, AND GINGIVITIS*

TWIN PACK *in laboratory tests

Neutralizes the source of bad breath*

*in laboratory tests

Gently whitens

Dr. Harold Katz

Fresh Mint

2 TUBES of 4.0 oz (113 g)

TOTAL NET WT. 8.0 oz (226 g)

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 the teeth. These may be signs or symptoms of periodontitis, a serious form of gum disease.


Advanced Ingredient Data


Raw Label Data

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