Whole Care Orange Mango

Dosage form: paste, dentifrice
Ingredients: Sodium fluoride 0.00243g in 1g
Labeler: Tom's of Maine, Inc.
NDC Code: 51009-119

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
WHOLE CARE
fluoride toothpaste gel

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

sorbitol, hydrated silica, water, glycerin, Citrus aurantium dulcis (orange) peel oil and other natural flavors, xylitol, sodium lauryl sulfate, zinc citrate, xanthan gum.

Questions?

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

PRINCIPAL DISPLAY PANEL - 133 g Carton

Since 1970
Tom's
OF MAINE

with fluoride | natural

WHOLE CARE®

fights cavities | whitening | fresh breath | helps fight tartar
fluoride toothpaste

orange mango gel

NET WT 4.7 OZ (133 g)

PRINCIPAL DISPLAY PANEL - 133 g Carton

Since 1970
Tom's
OF MAINE

with fluoride | natural

WHOLE CARE®

fights cavities | whitening | fresh breath | helps fight tartar
fluoride toothpaste

peppermint gel

NET WT 4.7 OZ (133 g)

PRINCIPAL DISPLAY PANEL - 133 g Carton

Since 1970
Tom's
OF MAINE

with fluoride | natural

WHOLE CARE®

fights cavities | whitening | fresh breath | helps fight tartar
fluoride toothpaste

spearmint gel

NET WT 4.7 OZ (133 g)

WHOLE CARE   ORANGE MANGO
sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51009-119
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium fluoride (Fluoride ion) Sodium fluoride0.00243 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
Sorbitol 
Hydrated Silica 
Glycerin 
Water 
Xylitol 
Sodium lauryl sulfate 
Zinc citrate 
Xanthan gum 
Mango 
Orange Oil 
Product Characteristics
Color    Score    
ShapeSize
FlavorORANGE, MANGO (Fruity) Imprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:51009-119-471 TUBE (TUBE) in 1 CARTON
1133 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35502/14/2011
WHOLE CARE   SPEARMINT
sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51009-153
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium fluoride (Fluoride ion) Sodium fluoride0.00243 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
Sorbitol 
Hydrated Silica 
Glycerin 
Water 
Xylitol 
Sodium lauryl sulfate 
Zinc citrate 
Xanthan gum 
Spearmint Oil 
Peppermint oil 
Product Characteristics
Color    Score    
ShapeSize
FlavorSPEARMINTImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:51009-153-471 TUBE (TUBE) in 1 CARTON
1133 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35502/14/2011
WHOLE CARE   PEPPERMINT
sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51009-158
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium fluoride (Fluoride ion) Sodium fluoride0.00243 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
Sorbitol 
Hydrated Silica 
Glycerin 
Water 
Xylitol 
Sodium lauryl sulfate 
Zinc citrate 
Xanthan gum 
Peppermint oil 
Product Characteristics
Color    Score    
ShapeSize
FlavorPEPPERMINTImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:51009-158-471 TUBE (TUBE) in 1 CARTON
1133 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35502/14/2011
Labeler - Tom's of Maine, Inc. (052764354)
Establishment
NameAddressID/FEIOperations
Tom's of Maine, Inc.052764354MANUFACTURE

Revised: 05/2011
 
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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