Therabreath Healthy Smile Oral Rinse

Therabreath Healthy Smile Oral Rinse
SPL v8
SPL
SPL Set ID 7f0e6864-5577-e368-e053-2a91aa0a57ca
Route
ORAL
Published
Effective Date 2019-03-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.0005 g)
Inactive Ingredients
Lemon Oil Sucralose Water Glycerin Xylitol Peg-40 Castor Oil Anhydrous Citric Acid Sodium Bicarbonate Sodium Hydroxide Menthol Sodium Chlorite Mentha Piperita Sodium Benzoate

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH FINAL Active Since 2018-10-02

Description

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

Purpose

Anticavity


Medication Information

Purpose

Anticavity

Description

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

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.

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.

Active Ingredient

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

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.

Healthy Smile Travel Size

Healthy Smile Travel Pouch 0.25 Oz

Therabreath Healthy Smile Oral Rinse


Structured Label Content

Uses

Aids in the prevention of dental cavities

Purpose

Anticavity

Warnings

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

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.

Active Ingredient

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

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.

Healthy Smile Travel Size

Healthy Smile Travel Pouch 0.25 Oz (Healthy Smile Travel Pouch 0.25 oz)

Therabreath Healthy Smile Oral Rinse (TheraBreath Healthy Smile Oral Rinse)


Advanced Ingredient Data


Raw Label Data

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