Simply White sweet mint

Dosage form: paste, dentifrice
Ingredients: Sodium fluoride 0.0024g in 1g
Labeler: Tom's of Maine, Inc.
NDC Code: 51009-149

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, Chondrus crispus (carrageenan).

Questions?

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

PRINCIPAL DISPLAY PANEL - 133.2g Tube Carton

new!

SINCE 1970
Tom's
OF MAINE

natural

SIMPLY WHITE®

whitening | cavity protection | fresh breath

fluoride toothpaste

sweet mint gel

NET WT 133.2g (4.7 OZ)

SIMPLY WHITE  SWEET MINT
sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51009-149
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
Water 
Silicon Dioxide 
Glycerin 
Xylitol 
Sodium lauryl sulfate 
Menthol 
Xanthan gum 
Peppermint oil 
Carrageenan 
Product Characteristics
Color    Score    
ShapeSize
FlavorMINT (Sweet Mint) Imprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:51009-149-061 TUBE (TUBE) in 1 CARTON
1133.2 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35503/12/2010
Labeler - Tom's of Maine, Inc. (052764354)
Establishment
NameAddressID/FEIOperations
Tom's of Maine, Inc.052764354MANUFACTURE

Revised: 03/2010
 
Tom's of Maine, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide
(web2)