SEA SALT ANTICAVITY SALT47  GENTLY SCRUBS AWAY SURFACE STAINS / FIGHTS BAD BREATH GERMS / STRENGTHENS ENAMEL- sodium fluoride paste, dentifrice 
Toms 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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Sea Salt Anticavity Toothpaste SALT47
gently scrubs away surface stains / fights bad breath germs / strengthens enamel

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

water, sorbitol, hydrated silica, xylitol, glycerin, sodium chloride, sodium lauryl sulfate, zinc citrate, natural flavor1, xanthan gum, carrageenan.


1
peppermint oil and other natural flavor

Questions?

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

PRINCIPAL DISPLAY PANEL - 133 g Tube Carton

4.7 OZ (133 g)

SINCE 1970
Tom's®
OF MAINE

natural
with fluoride

SEA SALT

anticavity toothpaste

gently scrubs away surface stains
fights bad breath germs
strengthens enamel

refreshing mint

with
purified
sea salt

PRINCIPAL DISPLAY PANEL - 133 g Tube Carton
SEA SALT ANTICAVITY SALT47   GENTLY SCRUBS AWAY SURFACE STAINS / FIGHTS BAD BREATH GERMS / STRENGTHENS ENAMEL
sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51009-901
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O) Fluoride Ion0.0024 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Sorbitol (UNII: 506T60A25R)  
Hydrated Silica (UNII: Y6O7T4G8P9)  
Xylitol (UNII: VCQ006KQ1E)  
Glycerin (UNII: PDC6A3C0OX)  
Sodium Chloride (UNII: 451W47IQ8X)  
Sodium Lauryl Sulfate (UNII: 368GB5141J)  
Zinc Citrate (UNII: K72I3DEX9B)  
Peppermint Oil (UNII: AV092KU4JH)  
Xanthan Gum (UNII: TTV12P4NEE)  
Carrageenan (UNII: 5C69YCD2YJ)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorPEPPERMINT (Refreshing Mint) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51009-901-471 in 1 CARTON11/12/2018
1133 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35511/12/2018
Labeler - Toms of Maine, Inc. (052764354)
Establishment
NameAddressID/FEIBusiness Operations
Toms of Maine, Inc.829517189MANUFACTURE(51009-901)

Revised: 8/2019
Document Id: 753cf656-e8fc-4824-a346-6d3231722c9a
Set id: a743bb22-bf93-4d10-820a-0a43bd1cb1d7
Version: 1
Effective Time: 20190830
 
Toms of Maine, Inc.