THERABREATH HEALTHY SMILE ORAL RINSE- sodium fluoride rinse

TheraBreath Healthy Smile Oral Rinse by

Drug Labeling and Warnings

TheraBreath Healthy Smile Oral Rinse by is a Otc medication manufactured, distributed, or labeled by Dr. Harold Katz, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

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

Purpose

Anticavity

Uses

Aids in the prevention of dental cavities

Warnings

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

Warnings

Directions

Adults and Children 6 years of age and 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.
• Instruct children under 12 years of age in good rinsing habits (to minimize swallowing).
• Supervise children as necessary until capable of using without supervision.
• Children under 6 years of age: consult a dentist or doctor.

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.

TheraBreath Healthy Smile Oral Rinse

Healthy Smile Travel Size

Healthy Smile Travel Pouch 0.25 oz

INGREDIENTS AND APPEARANCE

THERABREATH HEALTHY SMILE ORAL RINSE 
sodium fluoride rinse

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72551-246
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.0005 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
LEMON OIL (UNII: I9GRO824LL)
SUCRALOSE (UNII: 96K6UQ3ZD4)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
XYLITOL (UNII: VCQ006KQ1E)
PEG-40 CASTOR OIL (UNII: 4ERD2076EF)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
MENTHOL (UNII: L7T10EIP3A)
SODIUM CHLORITE (UNII: G538EBV4VF)
MENTHA PIPERITA (UNII: 79M2M2UDA9)
SODIUM BENZOATE (UNII: OJ245FE5EU)

Product Characteristics
Color	white (Clear)	Score
Shape		Size
Flavor	MINT (Clean Mint)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72551-246-01	473 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/01/2019
2	NDC: 72551-246-02	85 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/01/2019
3	NDC: 72551-246-03	7 g in 1 POUCH; Type 0: Not a Combination Product	03/19/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	10/02/2018

Labeler - Dr. Harold Katz, LLC (965507767)