Mentadent Advanced Breath Freshening - Two Refills

Drug Labeling and Warnings

Drug Details [pdf]

MENTADENT ADVANCED BREATH FRESHENING- sodium fluoride paste, dentifrice 
Church & Dwight Co., 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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Mentadent Advanced Breath Freshening - Two Refills

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

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 Carton image

MENTADENT  ADVANCED BREATH FRESHENING
sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 10237-616
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE2.4 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
SORBITOL (UNII: 506T60A25R)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
POLOXAMER 407 (UNII: TUF2IVW3M2)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
PEG-32 STEARATE (UNII: 33GX5WQC0M)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
ALCOHOL (UNII: 3K9958V90M)  
ZINC CITRATE (UNII: K72I3DEX9B)  
HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
PHOSPHORIC ACID (UNII: E4GA8884NN)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Product Characteristics
Colorblue, whiteScore    
ShapeSize
FlavorMINT (Mint Sparkle) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 10237-616-101 in 1 CARTON04/01/200410/28/2019
1148.8 g in 1 CARTRIDGE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35504/01/200410/28/2019
Labeler - Church & Dwight Co., Inc. (001211952)
Establishment
NameAddressID/FEIBusiness Operations
Church & Dwight Co., Inc.043690812manufacture(10237-616)

Revised: 10/2019