NATURAL PREBIOTIC PEPPERMINT PPBT4- sodium fluoride paste, dentifrice 
NATURAL PREBIOTIC SPEARMINT SPBT4- 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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Natural Prebiotic Toothpaste

Drugs 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

water, sorbitol, hydrated silica, glycerin, xylitol, inulin, sodium lauryl sulfate, zinc citrate, natural flavor, xanthan gum, benzyl alcohol, carrageenan.

Questions?

1-800-FOR-TOMS (1-800-367-8667)

DIST. BY TOM'S OF MAINE, INC., KENNEBUNK, ME 04043 U.S.A.

PRINCIPAL DISPLAY PANEL - 113 g Tube Carton - Peppermint

new

SINCE 1970
Tom's
OF MAINE®

PREBIOTIC
FLUORIDE TOOTHPASTE

HELPS SUPPORT GOOD BACTERIA
TO MAINTAIN HEALTHY BALANCE*

  • fights cavities
  • whitens teeth
  • strengthens enamel
  • fights tartar buildup
  • freshens breath

PEPPERMINT

4 OZ (113 g)

PRINCIPAL DISPLAY PANEL - 113 g Tube Carton - Peppermint

PRINCIPAL DISPLAY PANEL - 113 g Tube Carton - Spearmint

new

SINCE 1970
Tom's
OF MAINE®

NATURAL
PREBIOTIC
FLUORIDE TOOTHPASTE

HELPS SUPPORT GOOD BACTERIA
TO MAINTAIN HEALTHY BALANCE*

  • fights cavities
  • whitens teeth
  • strengthens enamel
  • fights tartar buildup
  • freshens breath

SPEARMINT

4 OZ (113 g)

PRINCIPAL DISPLAY PANEL - 113 g Tube Carton - Spearmint
NATURAL PREBIOTIC PEPPERMINT PPBT4 
sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51009-903
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.0015 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
XYLITOL (UNII: VCQ006KQ1E)  
ZINC CITRATE (UNII: K72I3DEX9B)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
XANTHAN GUM (UNII: TTV12P4NEE)  
CARRAGEENAN (UNII: 5C69YCD2YJ)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
GLYCERIN (UNII: PDC6A3C0OX)  
SORBITOL (UNII: 506T60A25R)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
INULIN (UNII: JOS53KRJ01)  
PEPPERMINT (UNII: V95R5KMY2B)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorPEPPERMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51009-903-041 in 1 CARTON11/29/201904/14/2022
1113 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35511/29/201904/14/2022
NATURAL PREBIOTIC SPEARMINT SPBT4 
sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51009-904
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.0015 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
XYLITOL (UNII: VCQ006KQ1E)  
ZINC CITRATE (UNII: K72I3DEX9B)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
XANTHAN GUM (UNII: TTV12P4NEE)  
CARRAGEENAN (UNII: 5C69YCD2YJ)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
GLYCERIN (UNII: PDC6A3C0OX)  
SORBITOL (UNII: 506T60A25R)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
INULIN (UNII: JOS53KRJ01)  
SPEARMINT (UNII: J7I2T6IV1N)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorSPEARMINT (Spearmint Ice) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51009-904-041 in 1 CARTON11/29/2019
1113 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35511/29/2019
Labeler - Tom's of Maine, Inc. (052764354)

Revised: 12/2022
 
Tom's of Maine, Inc.