CHILDRENS  SILLY STRAWBERRY- 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
OF MAINE
natural
children's
silly strawberry

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 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 flavors, Chondrus crispus (carrageenan), sodium lauryl sulfate.

Questions?

1-800-FOR-TOMS (1-800-367-8667) M - F 8:30 a.m. - 5:30 p.m. ET

PRINCIPAL DISPLAY PANEL - 24.7 g Carton

SINCE 1970
Tom's

OF MAINE

natural
children's

prevents cavities, tastes great
fluoride toothpaste

silly strawberry

ADA
Accepted

American
Dental
Association ®

NET WT .87 OZ (24.7 g)

Principal Display Panel - 24.7 g Carton
CHILDRENS   SILLY STRAWBERRY
sodium monofluorophosphate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51009-128
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium Monofluorophosphate (UNII: C810JCZ56Q) (fluoride ion - UNII:Q80VPU408O) Sodium Monofluorophosphate0.0076 g  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
ColorWHITEScore    
ShapeSize
FlavorSTRAWBERRY (with other natural fruit flavors) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51009-128-42119 g in 1 TUBE
2NDC:51009-128-011 in 1 CARTON
224.7 g in 1 TUBE
3NDC:51009-128-041 in 1 CARTON
3113 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35508/30/2010
Labeler - Tom's of Maine, Inc. (052764354)
Establishment
NameAddressID/FEIBusiness Operations
Tom's of Maine, Inc.052764354MANUFACTURE

Revised: 8/2010
Document Id: 81c745f1-4123-4e7a-9808-864dc83aab26
Set id: b31e5464-220b-4e6b-b71b-a0eb05418b42
Version: 1
Effective Time: 20100824
 
Tom's of Maine, Inc.