CHILDRENS OUTRAGEOUS ORANGE MANGO- 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

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 - 119 g Tube

SINCE 1970
Tom's™
OF MAINE

ADA
Accepted
American
Dental
Association ®

natural
children's

prevents
cavities

tastes great

fluoride toothpaste

outrageous
orange mango™

NET WT 4.2 OZ (119 g)

Principal Display Panel – 119 g Tube
CHILDRENS  OUTRAGEOUS ORANGE MANGO
sodium monofluorophosphate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51009-127
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)  
Orange (UNII: 5EVU04N5QU)  
Carrageenan (UNII: 5C69YCD2YJ)  
sodium lauryl sulfate (UNII: 368GB5141J)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorORANGE (Orange-mango with other natural fruit flavors) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51009-127-041 in 1 CARTON
1113 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35508/30/2010
CHILDRENS  OUTRAGEOUS ORANGE MANGO
sodium monofluorophosphate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51009-830
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)  
Orange (UNII: 5EVU04N5QU)  
Carrageenan (UNII: 5C69YCD2YJ)  
sodium lauryl sulfate (UNII: 368GB5141J)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorORANGE (Orange-mango with other natural fruit flavors) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51009-830-94119 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: 14754960-8e32-4c3c-b41d-f5ed6fdc2c74
Set id: 4d4cf5c7-bac2-46b2-bd71-bb27f2038286
Version: 1
Effective Time: 20100824
 
Tom's of Maine, Inc.