SIMPLY WHITE  SWEET MINT- sodium fluoride paste, dentifrice 
Tom's of Maine, 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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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)

PRINCIPAL DISPLAY PANEL - 133.2g Tube Carton
SIMPLY WHITE   SWEET MINT
sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51009-149
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE0.0024 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
SORBITOL (UNII: 506T60A25R)  
WATER (UNII: 059QF0KO0R)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
GLYCERIN (UNII: PDC6A3C0OX)  
XYLITOL (UNII: VCQ006KQ1E)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
XANTHAN GUM (UNII: TTV12P4NEE)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
CARRAGEENAN (UNII: 5C69YCD2YJ)  
ANISE (UNII: 21C2F5E8RE)  
VANILLIN (UNII: CHI530446X)  
CLOVE OIL (UNII: 578389D6D0)  
ZINGERONE (UNII: 4MMW850892)  
PIPERONAL (UNII: KE109YAK00)  
Product Characteristics
Color    Score    
ShapeSize
FlavorMINT (Sweet Mint) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51009-149-061 in 1 CARTON03/12/201012/30/2025
1133.2 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35503/12/201012/30/2025
Labeler - Tom's of Maine, Inc. (052764354)

Revised: 9/2023
Document Id: 49c5386e-4101-4375-a369-3d2aa48427b5
Set id: 55df245e-8e79-4d52-a591-6c45d3b92945
Version: 5
Effective Time: 20230919
 
Tom's of Maine, Inc.