therabreath for kids anti cavity oral rinse

therabreath for kids anti cavity oral rinse
SPL v7
SPL
SPL Set ID 7f34bc73-1940-07a7-e053-2a91aa0a1bfe
Route
oral
Published
Effective Date 2018-10-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
fluoride ion (0.0005 g)
Inactive Ingredients
water xylitol anhydrous citric acid sodium benzoate glycerin grape sodium citrate sucralose

Identifiers & Packaging

Marketing Status
otc monograph final active Since 2018-10-01

Purpose

Anticavity

Description

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


Medication Information

Warnings

Keep Out Of Reach of Children.

Purpose

Anticavity

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, Sodium Benzoate, Flavor (Organic), Xylitol, Citric Acid, Sucralose, Sodium Citrate

Description

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

Use

Aids in the prevention of dental cavities

Active Ingredient

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

Therabreath Kids Anti Cavity Oral Rinse


Structured Label Content

Warnings

Keep Out Of Reach of Children.

Purpose

Anticavity

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 (Other information)

Do not use if safety seal is broken or missing

Inactive Ingredients

Water, Glycerin, Sodium Benzoate, Flavor (Organic), Xylitol, Citric Acid, Sucralose, Sodium Citrate

Use

Aids in the prevention of dental cavities

Active Ingredient

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

Therabreath Kids Anti Cavity Oral Rinse (TheraBreath Kids Anti Cavity Oral Rinse)


Advanced Ingredient Data


Raw Label Data

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