BIOMIN RESTORE PLUS- sodium fluoride paste, dentifrice 
DRCOLLINS, INC.

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.

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BioMin Restore Plus

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

Carton Label

Tube Label

Tube label

BIOMIN RESTORE PLUS 
sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77055-100
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.53 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:77055-100-011 in 1 CARTON05/01/2020
1100 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35505/01/2020
Labeler - DRCOLLINS, INC. (022002951)

Revised: 4/2020
Document Id: a47a410f-3a69-2024-e053-2995a90acdaf
Set id: a47a410f-3a68-2024-e053-2995a90acdaf
Version: 1
Effective Time: 20200429
 
DRCOLLINS, INC.