Everest
FDA Label NDC 83199-101

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Alpine Dental, Inc. for the product Everest (NDC 83199-101). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, otc - keep out of reach of children, otc - do not use, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredient

Stannous Fluoride, 0.63%

Purpose

Anticavity/Antigingivitis

Uses

• Aids in the prevention of dental decay

• Helps prevent gingivitis

• Helps interfere with harmful effects of plaque associated with gingivitis

Warnings

Otc - Keep Out Of Reach Of Children

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.

Otc - Do Not Use

Do not swallow.

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

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

Other

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

Everest Oral Care

Perio Maintenance Oral Rinse

Antigingivitis + Anticavity

Advanced Fluoride Concentrate with Xylitol

Alcohol Free

Fruit

10 fl oz (296 mL)

20220819_83119_101_10 (20220819 83119 101 10)

20220819_83119_101_10 (20220819 83119 101 10)

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