Mentadent Advanced Breath Freshening

Generic Name: sodium fluoride
Dosage Form: paste, dentifrice

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 FACTS

Active ingredients        

Sodium fluoride (0.24%)

Purpose
Anticavity toothpaste

Use  aids in the prevention of dental decay

Warnings
Keep out of reach of children under 6 years of age.

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions    supervise children as necessary until capable of using without supervision
                   do not swallow

adults and children 2 years and older                brush teeth thoroughly after meals or at least twice a day, or use as directed by a dentist or physician
children under 6 years                                         instruct in good brushing and rinsing habits (to minimize swallowing)
children under 2 years                                         ask a dentist or physician

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Inactive ingredients   water, glycerin, sorbitol, hydrated silica, poloxamer 407, sodium bicarbonate, PEG-32, sodium lauryl sulfate, SD alcohol 38-B, zinc citrate trihydrate, flavor, hydrogen peroxide, cellulose gum, sodium saccharin, phosphoric acid, blue 1, titanium dioxide

Questions or comments?  Call 1-800-786-5135 Monday-Friday 9am-5pm ET

Principal Display Panel

MENTADENT
Anticavity Fluoride Toothpaste

Baking Soda and Peroxide
Advanced Breath Freshening

Mint Sparkle

with MICROBEADS and WHITENING CRYSTALS

NET WT. 5.25 OZ. (148.8g) EACH
TOTAL WT. 10.5 OZ. (297.6g) EACH


Carton image

MENTADENT  ADVANCED BREATH FRESHENING
sodium fluoride paste, dentifrice
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:10237-616
Route of Administration DENTAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE (FLUORIDE ION) SODIUM FLUORIDE 2.4 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
WATER  
GLYCERIN  
SORBITOL  
HYDRATED SILICA  
POLOXAMER 407  
SODIUM BICARBONATE  
PEG-32 STEARATE  
SODIUM LAURYL SULFATE  
ALCOHOL  
ZINC CITRATE  
HYDROGEN PEROXIDE  
CARBOXYMETHYLCELLULOSE SODIUM  
SACCHARIN SODIUM  
POLYETHYLENE GLYCOL  
PHOSPHORIC ACID  
SUCRALOSE  
TITANIUM DIOXIDE  
FD&C BLUE NO. 1  
Product Characteristics
Color blue, white Score     
Shape Size
Flavor MINT (Mint Sparkle) Imprint Code
Contains         
Packaging
# Item Code Package Description
1 NDC:10237-616-10 1 CARTRIDGE (CARTRIDGE) in 1 CARTON
1 148.8 g in 1 CARTRIDGE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part355 04/01/2004
Labeler - Church & Dwight Co., Inc. (001211952)
Establishment
Name Address ID/FEI Operations
Church & Dwight Co., Inc. 043690812 manufacture
Revised: 11/2010
 
Church & Dwight Co., Inc.



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