Colgate ULTRA BRITE Baking Soda and Peroxide Whitening

Dosage form: paste, dentifrice
Ingredients: SODIUM MONOFLUOROPHOSPHATE 7.6mg in 1g
Labeler: Mission Hills, S.A. de C.V.
NDC Code: 65954-063

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.

Colgate Ultra brite® BS&PW Fluoride Toothpaste

Drug Facts

Active ingredient

Sodium monofluorophosphate 0.76% (0.14% 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 contact a Poison Control Center right away.

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

glycerin, hydrated silica, water, sodium bicarbonate, PEG-12, sodium lauryl sulfate, flavor, sodium hydroxide, cellulose gum, carrageenan, sodium saccharin, calcium peroxide, titanium dioxide

Questions?

1-800-468-6502

Dist. by:
COLGATE-PALMOLIVE COMPANY
New York, NY 10022

PRINCIPAL DISPLAY PANEL - 170 g Tube Carton

COOL MINT

Ultra brite®
ANTICAVITY FLUORIDE TOOTHPASTE

NET WT 6.0 OZ (170 g)

DEEP CLEANS TEETH
Baking Soda
& Peroxide
Whitening
TOOTHPASTE

COLGATE   ULTRA BRITE BAKING SODA AND PEROXIDE WHITENING
sodium monofluorophosphate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65954-063
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM MONOFLUOROPHOSPHATE (FLUORIDE ION) SODIUM MONOFLUOROPHOSPHATE7.6 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
GLYCERIN491.6 mg  in 1 g
HYDRATED SILICA 
WATER 
SODIUM BICARBONATE 
POLYETHYLENE GLYCOL 600 
SODIUM LAURYL SULFATE 
SODIUM HYDROXIDE 
CARBOXYMETHYLCELLULOSE SODIUM 
CARRAGEENAN 
SACCHARIN SODIUM DIHYDRATE 
CALCIUM PEROXIDE 
TITANIUM DIOXIDE 
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorPEPPERMINTImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:65954-063-601 TUBE (TUBE) in 1 CARTON
1170 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35512/01/2011
Labeler - Mission Hills, S.A. de C.V. (812312122)

Revised: 01/2012
 
Mission Hills, S.A. de C.V.

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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