Synedent Flx 2 Oz

Synedent Flx 2 Oz
SPL v2
SPL
SPL Set ID a011ed68-86a0-5e59-e053-2995a90acedf
Route
ORAL
Published
Effective Date 2019-10-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.02 g)
Inactive Ingredients
Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2019-09-30

Description

Active Ingredients Sodium fluoride 0.05% (0.02% fluoride ion) Purpose Anticavity Use Aids in the prevention of dental cavities Warnings Keep out of reach of children. If more than indicated is swallowed, get medical attention or contact a Poison Control Center right away. Contains shellfish derivatives. Not to be used by pets. Do not use if safety seal is broken or missing. Directions Adults and children 6 years of age and older: Use once a day after brushing your teeth with toothpaste. Vigorously swish 10 milliliters (2 teaspoons) 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 Store at room temperature. Inactive Ingredients Water, Sorbitol, Glycerin, Xylitol, Polysorbate 20, Peppermint Oil, Benzoic Acid, ChitoTek (Chitosan Argininamide), Sodium Hydroxide Question? Call toll-free 855-774-7962

Purpose

Anticavity


Medication Information

Purpose

Anticavity

Description

Active Ingredients Sodium fluoride 0.05% (0.02% fluoride ion) Purpose Anticavity Use Aids in the prevention of dental cavities Warnings Keep out of reach of children. If more than indicated is swallowed, get medical attention or contact a Poison Control Center right away. Contains shellfish derivatives. Not to be used by pets. Do not use if safety seal is broken or missing. Directions Adults and children 6 years of age and older: Use once a day after brushing your teeth with toothpaste. Vigorously swish 10 milliliters (2 teaspoons) 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 Store at room temperature. Inactive Ingredients Water, Sorbitol, Glycerin, Xylitol, Polysorbate 20, Peppermint Oil, Benzoic Acid, ChitoTek (Chitosan Argininamide), Sodium Hydroxide Question? Call toll-free 855-774-7962

Use

Aids in the prevention of dental cavities

Labels

Warnings

If more than indicates is swallowed, get medical attention or contact Poison Control Center right away.

Contains shellfish derivatives.

Not to be used by pets.

Do not use if safety seal is broken or missing.

Directions

Adults and children 6 years of age and older: Use once a day after brushing your teeth with toothpaste. Vigorously swish 10 milliliters (2 teaspoons) 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.

Drug Facts

Active Ingredients

Sodium fluoride 0.05% (0.02% fluoride ion)

Purpose Anticavity

Use Aids in the prevention of dental cavities

Warnings

Keep out of reach of children.

If more than indicated is swallowed, get medical attention or contact a Poison Control Center right away. Contains shellfish derivatives. Not to be used by pets. Do not use if safety seal is broken or missing.

Directions

Adults and children 6 years of age and older: Use once a day after brushing your teeth with toothpaste. Vigorously swish 10 milliliters (2 teaspoons) 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

Store at room temperature.

Inactive Ingredients

Water, Sorbitol, Glycerin, Xylitol, Polysorbate 20, Peppermint Oil, Benzoic Acid, ChitoTek (Chitosan Argininamide), Sodium Hydroxide

Question?

Call toll-free 855-774-7962

Active Ingredients

Sodium fluoride 0.05%

(0.02% w/v fluoride ion)

Inactive Ingredients

Water, Sorbitol, Glycerin, Xylitol, Polysorbate 20, Peppermint Oil, Benzoic Acid, ChitoTek (Chitosan Argininamide), Sodium Hydroxide

Keep Out of Reach of Children

Keep out of reach of children


Structured Label Content

Use

Aids in the prevention of dental cavities

Labels

Purpose

Anticavity

Warnings

If more than indicates is swallowed, get medical attention or contact Poison Control Center right away.

Contains shellfish derivatives.

Not to be used by pets.

Do not use if safety seal is broken or missing.

Directions

Adults and children 6 years of age and older: Use once a day after brushing your teeth with toothpaste. Vigorously swish 10 milliliters (2 teaspoons) 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.

Drug Facts

Active Ingredients

Sodium fluoride 0.05% (0.02% fluoride ion)

Purpose Anticavity

Use Aids in the prevention of dental cavities

Warnings

Keep out of reach of children.

If more than indicated is swallowed, get medical attention or contact a Poison Control Center right away. Contains shellfish derivatives. Not to be used by pets. Do not use if safety seal is broken or missing.

Directions

Adults and children 6 years of age and older: Use once a day after brushing your teeth with toothpaste. Vigorously swish 10 milliliters (2 teaspoons) 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

Store at room temperature.

Inactive Ingredients

Water, Sorbitol, Glycerin, Xylitol, Polysorbate 20, Peppermint Oil, Benzoic Acid, ChitoTek (Chitosan Argininamide), Sodium Hydroxide

Question?

Call toll-free 855-774-7962

Active Ingredients

Sodium fluoride 0.05%

(0.02% w/v fluoride ion)

Inactive Ingredients

Water, Sorbitol, Glycerin, Xylitol, Polysorbate 20, Peppermint Oil, Benzoic Acid, ChitoTek (Chitosan Argininamide), Sodium Hydroxide

Keep Out of Reach of Children (Keep out of reach of children)

Keep out of reach of children


Advanced Ingredient Data


Raw Label Data

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