therabreath kids anticavity bubblegum

therabreath kids anticavity bubblegum
SPL v2
SPL
SPL Set ID 2770424d-7416-66d4-e063-6394a90ad4b1
Route
oral
Published
Effective Date 2024-11-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
fluoride ion (0.005 mg)
Inactive Ingredients
water citric acid monohydrate sucralose sodium bicarbonate cetylpyridinium chloride potassium sorbate glycerin

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2024-12-31

Purpose

Anticavity

Description

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


Medication Information

Warnings and Precautions

Warning

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 spitout

•do not swallow the rinse

• do not eat or drink for30 minutes after rinsing

• instruct children under 12 years of age in good rinsing

habits (to minimize swallowing)

• supervise childrenas necessary until capableof 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, flavor (organic), potassium sorbate,citric acid, sodium citrate, sodium bicarbonate, cetylpyridinium chloride, sucralose

Description

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

Use

aids in the prevention of dental cavities

Section 50565-1

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

Section 51945-4

STRENGTHENS TEETH & ENAMEL

TheraBreath

KIDS

DENTIST FORMULATED

ANTICAVITY

FLUORIDE ORAL RINSE

Dr. Harold Katz

Bubblegum Blast

No DYES

ALCOHOL-FREE

IMPORTANT: Read direcations for proper use.

16 fl. oz. (1 pt.) 473 mL

Active Ingredient

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


Structured Label Content

Warnings and Precautions (34071-1)

Warning

Purpose (PURPOSE)

Anticavity

Directions (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 spitout

•do not swallow the rinse

• do not eat or drink for30 minutes after rinsing

• instruct children under 12 years of age in good rinsing

habits (to minimize swallowing)

• supervise childrenas necessary until capableof 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 (INACTIVE INGREDIENTS)

water, glycerin, flavor (organic), potassium sorbate,citric acid, sodium citrate, sodium bicarbonate, cetylpyridinium chloride, sucralose

Use (USE)

aids in the prevention of dental cavities

Section 50565-1 (50565-1)

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

Section 51945-4 (51945-4)

STRENGTHENS TEETH & ENAMEL

TheraBreath

KIDS

DENTIST FORMULATED

ANTICAVITY

FLUORIDE ORAL RINSE

Dr. Harold Katz

Bubblegum Blast

No DYES

ALCOHOL-FREE

IMPORTANT: Read direcations for proper use.

16 fl. oz. (1 pt.) 473 mL

Active Ingredient (ACTIVE INGREDIENT)

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


Advanced Ingredient Data


Raw Label Data

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