Anticavity Fluoride Mouthwash

Anticavity Fluoride Mouthwash
SPL v1
SPL
SPL Set ID 80950a92-8332-4005-bea0-cff62b3a59fa
Route
ORAL
Published
Effective Date 2017-01-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.1 mg)
Inactive Ingredients
Water Glycerin Cetylpyridinium Chloride Saccharin Sodium Phosphoric Acid Methylparaben Poloxamer 407 Propylparaben Sodium Phosphate, Dibasic, Anhydrous Fd&c Blue No. 1

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2017-01-30

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

Directions

Adults and children 6 years of age and older: Use twice a day after brushing your teeth with a toothpaste.

Vigorously swish 10 mL (2 teaspoonfuls) 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 12 years of age in good rinsing habits (to minimize swallowing).

Supervise children as necessary until capable of using without supervision.

Close cap fully after use, until the cap is felt to “click”, to reengage the child resistant cap.

Children under 6 years of age: Consult a dentist or doctor

Active Ingredient

Sodium Fluoride 0.02% (0.01% w/v fluoride ion)

Inactive Ingredie

water, glycerin, flavor, cetylpyridinium chloride, sodium saccharin, phosphoric acid, methylparaben, poloxamer 407, propylparaben, disodium phosphate, blue 1

This rinse may cause temporary staining to the surface of teeth.

This is not harmful and adequate brushing may prevent its occurrence.

Other Information

Store at room temperature. Cold temperature may temporarily cloud this product.

Principal Display Panel

Anticavity Fluoride

Mouthwash

Sodium Fluoride Oral Solution

Minty Fresh

33.8 FL OZ (1 L)

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.


Structured Label Content

Use

Aids in the prevention of dental cavities

Section 42229-5 (42229-5)

Drug Facts

Purpose

Anticavity

Directions

Adults and children 6 years of age and older: Use twice a day after brushing your teeth with a toothpaste.

Vigorously swish 10 mL (2 teaspoonfuls) 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 12 years of age in good rinsing habits (to minimize swallowing).

Supervise children as necessary until capable of using without supervision.

Close cap fully after use, until the cap is felt to “click”, to reengage the child resistant cap.

Children under 6 years of age: Consult a dentist or doctor

Active Ingredient (Active ingredient)

Sodium Fluoride 0.02% (0.01% w/v fluoride ion)

Inactive Ingredie (Inactive ingredie)

water, glycerin, flavor, cetylpyridinium chloride, sodium saccharin, phosphoric acid, methylparaben, poloxamer 407, propylparaben, disodium phosphate, blue 1

This rinse may cause temporary staining to the surface of teeth.

This is not harmful and adequate brushing may prevent its occurrence.

Other Information (Other information)

Store at room temperature. Cold temperature may temporarily cloud this product.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Anticavity Fluoride

Mouthwash

Sodium Fluoride Oral Solution

Minty Fresh

33.8 FL OZ (1 L)

Keep Out of Reach of Children. (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.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)