Colgate Transformers Mild Bubblefruit Flavor

Dosage form: gel, dentifrice
Ingredients: Sodium Fluoride 2.4mg in 1g
Labeler: Colgate-Palmolive Canada
NDC Code: 51442-547

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®
Fluoride Toothpaste

TRANS
FORMERS

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 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

sorbitol, water, hydrated silica, PEG-12, cellulose gum, flavor, sodium lauryl sulfate, sodium saccharin, mica, titanium dioxide, FD&C blue no. 1

Questions or comments?

Call toll-free 1-800-468-6502

www.colgate.com
Made in Canada

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

PRINCIPAL DISPLAY PANEL - 130 g Tube Label

Colgate®
Fluoride Toothpaste

CLINICALLY PROVEN
Cavity & Enamel Protection

ADA
Accepted

American
Dental
Association ®

Toothpaste

TRANS
FORMERS

NET WT
4.6 OZ
(130 g)

MILD BUBBLE FRUIT® FLAVOR

COLGATE   TRANSFORMERS MILD BUBBLEFRUIT FLAVOR
sodium fluoride gel, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51442-547
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium Fluoride (FLUORIDE ION) Sodium Fluoride2.4 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
sorbitol 
water 
hydrated silica 
Polyethylene Glycol 600 
Carboxymethylcellulose Sodium 
sodium lauryl sulfate 
Saccharin Sodium 
mica 
titanium dioxide 
FD&C Blue no. 1 
Product Characteristics
ColorBLUE (Blue Pearlescent Gel) Score    
ShapeSize
FlavorFRUITImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:51442-547-46130 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35503/16/2011
Labeler - Colgate-Palmolive Canada (259157246)

Revised: 03/2011
 
Colgate-Palmolive Canada

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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