BIOMIN RESTORE PLUS- sodium fluoride paste, dentifrice

Biomin Restore Plus by

Drug Labeling and Warnings

Biomin Restore Plus by is a Otc medication manufactured, distributed, or labeled by DRCOLLINS, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Purpose

Anticavity & Sensitivity Relief

Indications for Use

Fluoride dentifrice for use in the prevention and treatment of dental sensitivity.

Instructions for Use

Remove foil cover from nozzle, do not use if this seal has been broken. Brush twice daily for 2 minutes, ideally first thing in the morning and last thing at night, swirl the foamy dentifrice around your mouth for 30 seconds, and spit out. Do not swallow. Avoid rinsing your mouth
with water after brushing. Replace cap after use to keep dentifrice dry.

Warnings and Precautions

Continued tooth pain or sensitivivity could indicate an inherent problem that needs professional diagnosis. If symptoms persist consult your dentist. If irritation occurs, discontinue use.

Keep Out of Reach of Children

Keep Out of Reach of Children. For Adults Use Only.

Warning

DO NOT USE IF YOU ARE ALLERGIC TO ANY OF THE INGREDIENTS

Active Ingredient

Sodium Fluoride. (Fluoride concentration is 530μg/g by weight.)

Inactive Ingredients

Glycerin, Silica, PEG 400, Cocomidapropyl Betaine, Sodium Methyl Cocoyl Taurate, Titanium Dioxide, Aroma, Carbomer, Potassium Acesulfame.

Dosage & Administration

Net Wt. 3.35oz (100g)

75ml e / 100g ℮ / 3.5oz ℮.

Storage & Handling

Storage temperatures limit: up to 30°C.

Do ot use if package is damaged.

Carton

Tube Label

INGREDIENTS AND APPEARANCE

BIOMIN RESTORE PLUS 
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77055-100
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.53 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G)	0.0055 g  in 1 g
GLYCERIN (UNII: PDC6A3C0OX)	0.573 g  in 1 g
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)	0.0055 g  in 1 g
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)	0.156 g  in 1 g
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)	0.18 g  in 1 g
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)	0.0075 g  in 1 g
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)	0.004 g  in 1 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)	0.01 g  in 1 g
PEPPERMINT (UNII: V95R5KMY2B)	0.0085 g  in 1 g

Product Characteristics
Color		Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77055-100-01	1 in 1 CARTON	05/01/2020
1		100 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	05/01/2020

Labeler - DRCOLLINS, INC. (022002951)