TOMS CHILDRENS FLUORIDE SILLY STRAWBERRY  PREVENTS CAVITIES / TASTES GREAT / DYE FREE- sodium monofluorophosphate 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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Tom's Children's Fluoride Silly Strawberry™ Toothpaste

Drug Facts

Active ingredient

Sodium monofluorophosphate 0.76% (0.13% 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

glycerin, water, calcium carbonate, hydrated silica, natural flavor1, carrageenan, sodium lauryl sulfate.

1
Strawberry juice and other natural flavor

Questions?

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

PRINCIPAL DISPLAY PANEL - 21.2 g Tube Free Sample Card

PRINCIPAL DISPLAY PANEL - 21.2 g Tube Free Sample Card
TOMS CHILDRENS FLUORIDE SILLY STRAWBERRY   PREVENTS CAVITIES / TASTES GREAT / DYE FREE
sodium monofluorophosphate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51009-215
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium monofluorophosphate (UNII: C810JCZ56Q) (Fluoride ion - UNII:Q80VPU408O) Fluoride ion1.4 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Glycerin (UNII: PDC6A3C0OX)  
Water (UNII: 059QF0KO0R)  
Calcium carbonate (UNII: H0G9379FGK)  
Hydrated Silica (UNII: Y6O7T4G8P9)  
Strawberry (UNII: 4J2TY8Y81V)  
Carrageenan (UNII: 5C69YCD2YJ)  
Sodium Lauryl Sulfate (UNII: 368GB5141J)  
Product Characteristics
ColorWHITE (Off White) Score    
ShapeSize
FlavorSTRAWBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51009-215-0121.2 g in 1 TUBE; Type 0: Not a Combination Product04/01/201505/11/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35504/01/201505/11/2016
Labeler - Tom's of Maine, Inc. (052764354)

Revised: 12/2018
Document Id: 13a9513b-2fe2-4e74-bd20-7f4902e13241
Set id: 2ea1e695-4505-41a9-a2d8-11a577a484ff
Version: 2
Effective Time: 20181210
 
Tom's of Maine, Inc.