EVERNAMEL- stannous fluoride paste, dentifrice

Evernamel by

Drug Labeling and Warnings

Evernamel 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 Ingredients

Stannous Fluoride, 0.454%

Purpose

Anti-cavity & Anti-gingivitis

Uses

Builds up the enamel of teeth
Aids in the prevention of cavities
Helps prevent gingivitis
Helps sensitive teeth

Warnings

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children under 12 years of age.
If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

Remove seal
Apply a pea-sized amount of paste to the wet toothbrush

Adults and Children 12 years or older:
Brush teeth thoroughly for one minute after ach meal at least twice a day (or as directed by a dentist or physician)
Do not swallow

Children under 12 years of age: ask a dentist

Other Information

Everest enamel was specially formulated to prevent surface stains on the teeth, which otherwise can occur while using Stannous Fluoride.

Adequate tooth brushing may also prevent Stannous Fluoride stains which are not harmful or permanent and can be removed by a Dentist

Inactive Ingredients

Water, Sorbitol, Hydrated Silica, Xylitol, Glycerin, Sodium Gluconate, Flavor, Zinc Citrate, Quillaja Saponica Bark Extract, Cocamidopropyl Betaine, Titanium Dioxide, Smilax Aristolochiaefolia Root Extract, Sodium Hydroxide, Sodium Hydroxide, Sodium Tripolyphosphate, Tocopheryl Acetate, Xanthan Gum, Natural Menthol, Yucca Schidigera Rooth Extract, Dioscorea Villosa Root Extract

Questions or comments?

Call toll free 1-800-553-3682

SPL UNCLASSIFIED SECTION

Manufactured for:

Alpine Dental, Inc.

Brooklyn, NY 11218

Made in the USA

Item Code 1520-10

Evernamel

Brush Your Way To a Brighter Smile

Fresh Spearmint

Evernamel

Toothpaste with Remineralizing Benefits

Anticavity / Antigingivitis / Sensitivity Relief

122 g / 4.3 oz.

INGREDIENTS AND APPEARANCE

EVERNAMEL 
stannous fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83199-102
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
STANNOUS FLUORIDE (UNII: 3FTR44B32Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.454 mg  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
XYLITOL (UNII: VCQ006KQ1E)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM GLUCONATE (UNII: R6Q3791S76)
ZINC CITRATE (UNII: K72I3DEX9B)
QUILLAJA SAPONARIA BARK (UNII: 8N0K3807ZW)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SMILAX ARISTOLOCHIIFOLIA ROOT (UNII: NR100Y25G0)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SODIUM TRIPOLYPHOSPHATE (UNII: 5HK03SA80J)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
XANTHAN GUM (UNII: TTV12P4NEE)
MENTHOL (UNII: L7T10EIP3A)
YUCCA SCHIDIGERA ROOT (UNII: E2H9ET15AT)
DIOSCOREA VILLOSA WHOLE (UNII: Z95519QROX)

Product Characteristics
Color		Score
Shape		Size
Flavor	SPEARMINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83199-102-43	122 g in 1 TUBE; Type 0: Not a Combination Product	01/23/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	01/23/2023

Labeler - Alpine Dental, Inc. (037301378)

Establishment
Name	Address	ID/FEI	Business Operations
Dharma Research, Inc.		078444642	manufacture(83199-102)