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Simply White clean mint by Tom's of Maine, Inc.

Dosage form: paste, dentifrice
Ingredients: Sodium fluoride 0.00243g in 1g
Labeler: Tom's of Maine, Inc.
NDC Code: 51009-248

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.

Tom's
OF MAINE ®
SIMPLY WHITE®
fluoride toothpaste
clean mint

Drug Facts

Active ingredient

Sodium fluoride 0.24% (0.15% w/v fluoride ion)

Purpose

Anticavity

Use

helps protect against cavities

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 dial (412) 390-3381 right away (Poison Control Center).

Directions
adults and children 2 years of age and olderbrush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician
children 2 to 6 yearsuse only a pea-sized amount and supervise child's brushing and rinsing (to minimize swallowing)
children under 2 yearsask a dentist or physician

Inactive ingredients

hydrated silica, water, sorbitol, glycerin, xylitol, sodium lauryl sulfate, Mentha piperita (peppermint) oil and other natural flavors, xanthan gum, titanium dioxide, Chondrus crispus (carrageenan), sodium hydroxide.

Questions?

1-800-FOR-TOMS (1-800-367-8667) M - F 8:30 a.m. - 5 p.m. ET

PRINCIPAL DISPLAY PANEL 133 g Carton

SINCE 1970
Tom's
OF MAINE ®

ADA
Accepted

American
Dental
Association ®

clinically proven   |   natural

SIMPLY WHITE®

whitening   |   cavity protection

fluoride toothpaste

clean mint

NET WT 4.7 OZ (133 g)

SIMPLY WHITE  CLEAN MINT
sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51009-248
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium fluoride (fluoride ion) Sodium fluoride0.00243 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
Sorbitol 
Water 
Hydrated Silica 
Glycerin 
Xylitol 
Sodium lauryl sulfate 
Menthol 
Xanthan gum 
Peppermint oil 
Carrageenan 
Titanium dioxide 
Sodium hydroxide 
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorMINT (Clean Mint) Imprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:51009-248-471 TUBE (TUBE) in 1 CARTON
1133 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35508/29/2011
Labeler - Tom's of Maine, Inc. (052764354)
Establishment
NameAddressID/FEIOperations
Tom's of Maine, Inc.052764354MANUFACTURE

 
Tom's of Maine, Inc.

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Medically reviewed on Aug 30, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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