THERABREATH HEALTHY GUMS- stannous fluoride paste, dentifrice

Therabreath by

Drug Labeling and Warnings

Therabreath by is a Otc medication manufactured, distributed, or labeled by Church & Dwight Co., Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

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

Purpose

Anticavity/Antigingivitis

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

Warnings

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.

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

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 08628 U.S.A

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

PRINCIPAL DISPLAY PANEL

LONG LASTING FOR EPIC FRESHNESS

TheraBreath™

HEALTHY GUMS

DENTIST FORMULATED TOOTHPASTE

Anticavity/Antigingivitis

REDUCES GUMLINE PLAQUE FOR 24 HOURS*

TWIN PACK *in a clinical study with twice daily brushing vs a regular toothpaste

Neutralizes the source of bad breath t

tin laboratory tests

Gently whitens

Dr. Harold Katz

Clean Mint

2 TUBES of 4.0 oz (113 g)

TOTAL NET WT. 8.0 oz (226 g)

INGREDIENTS AND APPEARANCE

THERABREATH  HEALTHY GUMS
stannous fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10237-271
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
STANNOUS FLUORIDE (UNII: 3FTR44B32Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.454 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
PEG-8 (UNII: B697894SGQ)
SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
PENTASODIUM TRIPHOSPHATE (UNII: 9SW4PFD2FZ)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
XANTHAN GUM (UNII: TTV12P4NEE)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
SUCRALOSE (UNII: 96K6UQ3ZD4)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	white	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10237-271-24	2 in 1 CARTON	08/01/2025
1		113 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 10237-271-07	1 in 1 CARTON	09/15/2025
2		19 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 10237-271-04	1 in 1 CARTON	12/15/2025
3		113 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M021	08/01/2025

Labeler - Church & Dwight Co., Inc. (001211952)

Establishment
Name	Address	ID/FEI	Business Operations
Church & Dwight Co., Inc.		043690812	manufacture(10237-271)