Therabreath™ Whitening Dentist Formulated Toothpaste

Therabreath™ Whitening Dentist Formulated Toothpaste
SPL v2
SPL
SPL Set ID 3ba04b55-38f9-76f3-e063-6394a90a3c03
Route
ORAL
Published
Effective Date 2025-08-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.243 g)
Inactive Ingredients
Water Sodium Bicarbonate Sodium Tripolyphosphate Sodium Lauroyl Sarcosinate Sucralose Titanium Dioxide Sorbitol Hydrated Silica Sodium Lauryl Sulfate Poloxamer 407 Glycerin Sodium Saccharin Tetrasodium Pyrophosphate Xanthan Gum

Identifiers & Packaging

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

Description

Drug Facts

Purpose

Anticavity


Medication Information

Warnings and Precautions

Warning

Purpose

Anticavity

Description

Drug Facts

Use

aids in the prevention of dental decay

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

Sodium fluoride 0.24% (0.17% w/v fluoride ion)

Inactive Ingredients

water, sodium bicarbonate, sorbitol, hydrated silica, glycerin, tetrasodium pyrophosphate, sodium tripolyphosphate, flavor, sodium lauryI sulfate, sodium lauroyl sarcosinate, poloxamer 407, xanthan gum, titanium dioxide, sodium saccharin, sucralose

Questions Or Comments?

TheraBreath is manufactured by

Church & Dwight Co., Inc. Ewing, NJ 08628 U.S.A.

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

Prinicpal Display Panel

LONG LASTING FOR EPIC FRESHNESS

TheraBreath

WHITENING

DENTIST FORMULATED TOOTHPASTE

Anticavity

SIGNIFICANTLY WHITENS AFTER 1 WEEK*

TWIN PACK *with twice daily brushing

Neutralizes the source of bad breath t

tin laboratory tests

Gently whitens

Dr. Harold Katz

Dazzling Mint

2 TUBES of 4.0 oz (113 g)

TOTAL NET WT. 8.0 oz (226 g)


Structured Label Content

Use

aids in the prevention of dental decay

Warnings and Precautions (34071-1)

Warning

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

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

Sodium fluoride 0.24% (0.17% w/v fluoride ion)

Inactive Ingredients

water, sodium bicarbonate, sorbitol, hydrated silica, glycerin, tetrasodium pyrophosphate, sodium tripolyphosphate, flavor, sodium lauryI sulfate, sodium lauroyl sarcosinate, poloxamer 407, xanthan gum, titanium dioxide, sodium saccharin, sucralose

Questions Or Comments? (Questions or Comments?)

TheraBreath is manufactured by

Church & Dwight Co., Inc. Ewing, NJ 08628 U.S.A.

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

Prinicpal Display Panel

LONG LASTING FOR EPIC FRESHNESS

TheraBreath

WHITENING

DENTIST FORMULATED TOOTHPASTE

Anticavity

SIGNIFICANTLY WHITENS AFTER 1 WEEK*

TWIN PACK *with twice daily brushing

Neutralizes the source of bad breath t

tin laboratory tests

Gently whitens

Dr. Harold Katz

Dazzling Mint

2 TUBES of 4.0 oz (113 g)

TOTAL NET WT. 8.0 oz (226 g)


Advanced Ingredient Data


Raw Label Data

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