EVEREST- stannous fluoride rinse

Everest by

Drug Labeling and Warnings

Everest by is a Otc medication manufactured, distributed, or labeled by Alpine Dental, Inc., Dharma Research, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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.

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 acid, Flavor, Glycerin, Saccharin Sodium, Xylitol

SPL UNCLASSIFIED SECTION

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

Mint

10 fl oz (296 mL)

INGREDIENTS AND APPEARANCE

EVEREST 
stannous fluoride rinse

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83199-100
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
STANNOUS FLUORIDE (UNII: 3FTR44B32Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.63 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
EDETIC ACID (UNII: 9G34HU7RV0)
GLYCERIN (UNII: PDC6A3C0OX)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
XYLITOL (UNII: VCQ006KQ1E)

Product Characteristics
Color		Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83199-100-10	269 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	07/24/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	07/24/2020

Labeler - Alpine Dental, Inc. (037301378)

Establishment
Name	Address	ID/FEI	Business Operations
Dharma Research, Inc.		078444642	manufacture(83199-100)