Therabreath™ Anticavity Oral Rinse Sparkle Mint 0.05

Therabreath™ Anticavity Oral Rinse Sparkle Mint 0.05
SPL v4
SPL
SPL Set ID feab3d45-ff95-4b32-8258-7d932a7380c9
Route
ORAL
Published
Effective Date 2025-05-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.005 mg)
Inactive Ingredients
Water Glycerin Sodium Benzoate Sodium Hydroxide Sodium Chlorite Xylitol Citric Acid Monohydrate Sucralose Sodium Citrate, Unspecified Form

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-02-13 Until 2026-09-13

Description

Drug Facts

Purpose

Anticavity


Medication Information

Purpose

Anticavity

Description

Drug Facts

Use

Aids in the prevention of dental cavities

Section 42229-5

Drug Facts

Section 50565-1

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

Active Ingredients

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

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

USE 1X DAILY

ANTICAVITY FLUORIDE RINSE

TheraBreath™

DENTIST FORMULATED

ANTICAVITY

ORAL RINSE

HELPS FIGHT CAVITIES FOR 12 HOURS*

STRENGTHENS TEETH + ENAMEL • FRESHENS BREATH

Helps rebuild weakened tooth enamel and prevent cavities

No Alcohol • Powered by Fluoride • Non-Burning

Sodium Fluoride 0.05%

IMPORTANT:

Read directions for proper use.

Dr. Harold Katz

16 fl.oz. (1 pt.)

473 mL

SPARKLE MINT


Structured Label Content

Use

Aids in the prevention of dental cavities

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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.

Purpose

Anticavity

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 (Other information)

Do not use if safety seal is broken or missing

Active Ingredients

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

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 (PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label)

USE 1X DAILY

ANTICAVITY FLUORIDE RINSE

TheraBreath™

DENTIST FORMULATED

ANTICAVITY

ORAL RINSE

HELPS FIGHT CAVITIES FOR 12 HOURS*

STRENGTHENS TEETH + ENAMEL • FRESHENS BREATH

Helps rebuild weakened tooth enamel and prevent cavities

No Alcohol • Powered by Fluoride • Non-Burning

Sodium Fluoride 0.05%

IMPORTANT:

Read directions for proper use.

Dr. Harold Katz

16 fl.oz. (1 pt.)

473 mL

SPARKLE MINT


Advanced Ingredient Data


Raw Label Data

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