Childrens Outrageous Orange Mango

Dosage form: paste, dentifrice
Ingredients: Sodium Monofluorophosphate 0.0076g in 1g
Labeler: Tom's of Maine, Inc.
NDC Code: 51009-127

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.

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)

CHILDRENS  OUTRAGEOUS ORANGE MANGO
sodium monofluorophosphate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51009-127
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium Monofluorophosphate (fluoride ion) Sodium Monofluorophosphate0.0076 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
Glycerin 
Water 
Calcium carbonate 
Hydrated silica 
Orange 
Carrageenan 
sodium lauryl sulfate 
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorORANGE (Orange-mango with other natural fruit flavors) Imprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:51009-127-041 TUBE (TUBE) 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 AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium Monofluorophosphate (fluoride ion) Sodium Monofluorophosphate0.0076 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
Glycerin 
Water 
Calcium carbonate 
Hydrated silica 
Orange 
Carrageenan 
sodium lauryl sulfate 
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorORANGE (Orange-mango with other natural fruit flavors) Imprint Code
Contains    
Packaging
#Item CodePackage Description
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/FEIOperations
Tom's of Maine, Inc.052764354MANUFACTURE

Revised: 08/2010
 
Tom's of Maine, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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