Label: EVEREST- stannous fluoride rinse
- NDC Code(s): 83199-100-10
- Packager: Alpine Dental, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated July 24, 2020
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Uses
- Warnings
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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
- Inactive Ingredients
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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
-
INGREDIENTS AND APPEARANCE
EVEREST
stannous fluoride rinseProduct 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)
