THERABREATH ANTICAVITY- sodium fluoride rinse

Therabreath Anticavity by

Drug Labeling and Warnings

Therabreath Anticavity 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 Ingredients

Sodium Fluoride 0.05% (0.02% w/v fluoride ion)

Purpose

Anticavity

Use

Aids in the prevention of dental cavities

Warnings

Keep out of the reach of children. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

Adults and Children 18 years of age or older:

• Use once a day after brushing your teeth with a toothpaste.
• Vigorously swish 10 milliliters of rinse between your teeth for 1 minute and then spit out.
• Do not swallow the rinse.
• Do not eat or drink for 30 minutes after rinsing.

Other information

Do not use if safety seal is broken or missing

Inactive Ingredients

Water, Glycerin, PEG-40 Hydrogenated Castor Oil, Citric Acid, Sodium Hydroxide, Sodium Chlorite, Menthol, Citrus Lemon Peel Oil, Mentha Piperita Oil, Sodium Benzoate, Sucralose, Xylitol, Sodium Bicarbonate.

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

FORMERLY
KNOWN AS
HEALTHY
SMILE

ANTICAVITY FLUORIDE RINSE

Thera Breath™
DENTIST FORMULATED
ANTICAVITY
ORAL RINSE

HELPS FIGHT CAVITIES FOR 24 HOURS*
STRENGTHENS TEETH + ENAMEL FRESHENS BREATH

Helps rebuild weakened tooth enamel and prevent tooth decay

No Alcohol With Fluoride Non Burning

IMPORTANT:
Read directions
for proper use.

16 fl.oz.
473 mL

SPARKLE MINT

INGREDIENTS AND APPEARANCE

THERABREATH ANTICAVITY 
sodium fluoride rinse

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10237-260
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.005 mg  in 10 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SODIUM CHLORITE (UNII: G538EBV4VF)
XYLITOL (UNII: VCQ006KQ1E)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SUCRALOSE (UNII: 96K6UQ3ZD4)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)

Product Characteristics
Color		Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10237-260-16	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/13/2023
2	NDC: 10237-260-01	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/13/2023
3	NDC: 10237-260-03	88.7 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/13/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH DRUG	M021	02/13/2023

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