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

Medically reviewed on Feb 5, 2018

Dosage form: paste, dentifrice
Ingredients: Sodium fluoride 0.0024g in 1g
Labeler: Tom's of Maine, Inc.
NDC Code: 51009-148

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.

SIMPLY WHITE®

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 the 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 older:brush 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, natural flavors, xanthan gum, titanium dioxide, Chondrus crispus (carrageenan).

Questions?

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

© 2010 Tom's of Maine, Inc., 302 Lafayette Ctr., Kennebunk, ME 04043
Made in U.S.A.

PRINCIPAL DISPLAY PANEL - 133.2g Tube Carton

new!

SINCE 1970
Tom's
OF MAINE™

natural

SIMPLY WHITE®
whitening | cavity protection | fresh breath
fluoride toothpaste
clean mint

NET WT 133.2g (4.7 OZ)

SIMPLY WHITE  CLEAN MINT
sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51009-148
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium fluoride (fluoride ion) Sodium fluoride0.0024 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
Sorbitol 
Water 
Silicon Dioxide 
Glycerin 
Xylitol 
Sodium lauryl sulfate 
Menthol 
Xanthan gum 
Peppermint oil 
Carrageenan 
Spearmint oil 
Titanium dioxide 
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorMINT (Clean Mint) Imprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:51009-148-471 TUBE (TUBE) in 1 CARTON
1133.2 g in 1 TUBE
2NDC:51009-148-011 TUBE (TUBE) in 1 CARTON
225 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35502/04/2011
Labeler - Tom's of Maine, Inc. (052764354)
Establishment
NameAddressID/FEIOperations
Tom's of Maine, Inc.052764354MANUFACTURE
Establishment
NameAddressID/FEIOperations
Colgate-Palmolive Canada, Inc.259157246MANUFACTURE

 
Tom's of Maine, Inc.

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Further information

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

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