SPL v1
SPL
SPL Set ID 6ea0b178-4b5b-44a9-bfa2-11c0dc63a6b5
Route
DENTAL
Published
Effective Date 2023-01-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.63 mg)
Inactive Ingredients
Edetic Acid Glycerin Saccharin Sodium Xylitol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2022-08-19

Description

Stannous Fluoride, 0.63%

Purpose

Anticavity/Antigingivitis


Medication Information

Purpose

Anticavity/Antigingivitis

Description

Stannous Fluoride, 0.63%

Uses

• Aids in the prevention of dental decay

• Helps prevent gingivitis

• Helps interfere with harmful effects of plaque associated with gingivitis

Section 42229-5

For a Healthier & Happier Mouth

EVEREST Periodontal Rinse works immidately to disinfect, prevent decay, and reduce painful tooth & gum sensitivity.

Gentle on your teeth and tough on cavities - for a deeper clean you'll feel all day.

Prevents Gingivitis

Reduce Gum Bleeding

Plaque Crusher

Freshens Breath

Manufactured by:

Alpine Dental, Inc.

Brooklyn, NY 11218

1-800-553-3682

Made in USA

Section 50565-1

Keep out of reach of children under 6 years of age.  If more than used for rinsing is swallowed, get medical help or contact a Poison Control Center right away.

Section 50570-1

Do not swallow.

Warnings

Directions

• Do not use before mixing with water

• Adults and children 6 years of age and older:

- Use once per day after brushing your teeth with toothpaste

- Remove cap and replace with pump

- Rotate spout counter clockwise to extend

- Depress pump until rinse comes to the tip of the pump

- Pump 1/8 fl. oz. into a cup.

- Add water to the line (1 fl. oz.) on cup.

- Mix using bristle end of toothbrush

- Vigorously swish rinse between your teeth for 1 min. and then spit out.

- Do not swallow the rinse

- Do not eat or drink for 30 min. after rinsing

- Instruct children under 12 in good rinsing habits to minimize swallowing.

- Supervise children as necessary until capable of using without supervision

• Children under 6: Consult a dentist or doctor

Active Ingredient

Stannous Fluoride, 0.63%

Everest Oral Care

Perio Maintenance Oral Rinse

Antigingivitis + Anticavity

Advanced Fluoride Concentrate with Xylitol

Alcohol Free

Fruit

10 fl oz (296 mL)

Other Information

• Store at room temperature 59 – 86°F (15 – 30°C).

• This product may produce surface staining of the teeth. Adequate tooth brushing may prevent these stains which are not harmful or permanent

   and may be removed by your dentist.

Inactive Ingredients

Edetic actd, Flavor, Glycerin, Saccharin Sodium, Xylitol


Structured Label Content

Uses

• Aids in the prevention of dental decay

• Helps prevent gingivitis

• Helps interfere with harmful effects of plaque associated with gingivitis

Section 42229-5 (42229-5)

For a Healthier & Happier Mouth

EVEREST Periodontal Rinse works immidately to disinfect, prevent decay, and reduce painful tooth & gum sensitivity.

Gentle on your teeth and tough on cavities - for a deeper clean you'll feel all day.

Prevents Gingivitis

Reduce Gum Bleeding

Plaque Crusher

Freshens Breath

Manufactured by:

Alpine Dental, Inc.

Brooklyn, NY 11218

1-800-553-3682

Made in USA

Section 50565-1 (50565-1)

Keep out of reach of children under 6 years of age.  If more than used for rinsing is swallowed, get medical help or contact a Poison Control Center right away.

Section 50570-1 (50570-1)

Do not swallow.

Purpose

Anticavity/Antigingivitis

Warnings

Directions

• Do not use before mixing with water

• Adults and children 6 years of age and older:

- Use once per day after brushing your teeth with toothpaste

- Remove cap and replace with pump

- Rotate spout counter clockwise to extend

- Depress pump until rinse comes to the tip of the pump

- Pump 1/8 fl. oz. into a cup.

- Add water to the line (1 fl. oz.) on cup.

- Mix using bristle end of toothbrush

- Vigorously swish rinse between your teeth for 1 min. and then spit out.

- Do not swallow the rinse

- Do not eat or drink for 30 min. after rinsing

- Instruct children under 12 in good rinsing habits to minimize swallowing.

- Supervise children as necessary until capable of using without supervision

• Children under 6: Consult a dentist or doctor

Active Ingredient

Stannous Fluoride, 0.63%

Everest Oral Care

Perio Maintenance Oral Rinse

Antigingivitis + Anticavity

Advanced Fluoride Concentrate with Xylitol

Alcohol Free

Fruit

10 fl oz (296 mL)

Other Information

• Store at room temperature 59 – 86°F (15 – 30°C).

• This product may produce surface staining of the teeth. Adequate tooth brushing may prevent these stains which are not harmful or permanent

   and may be removed by your dentist.

Inactive Ingredients

Edetic actd, Flavor, Glycerin, Saccharin Sodium, Xylitol


Advanced Ingredient Data


Raw Label Data

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