COLGATE LUMINOUS CRYSTAL FLUORIDE- fluoride ion gel, dentifrice 
Mission Hills S.A. de C.V.

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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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 the 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, sodium lauryl sulfate, flavor, cellulose gum, tetrasodium pyrophosphate, cocamidopropyl betaine, sodium saccharin, mica, titanium dioxide, FD&C blue no.1

Questions or comments?

Call toll-free 1-800-468-6502

Dist. by:
COLGATE-PALMOLIVE COMPANY
New York, NY 10022
Made in Mexico
www.colgateluminous.com

PRINCIPAL DISPLAY PANEL - 113 g carton

Colgate®
Fluoride Toothpaste

ADA
Accepted

American
Dental
Association ®

NET WT 4.0 OZ (113 g)

LUMINOUS
Enamel Strengthening

CRYSTAL CLEAN MINT™

33%
FREE
3.0oz + 1.0oz

Principal Display Panel - 113 g carton
COLGATE LUMINOUS CRYSTAL FLUORIDE 
fluoride ion gel, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65954-022
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FLUORIDE ION (FLUORIDE ION) FLUORIDE ION2.4 mg  in 1 g
Product Characteristics
ColorBLUE (sky blue) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:65954-022-691 in 1 CARTON
1113 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35511/03/2009
Labeler - Mission Hills S.A. de C.V. (812312122)

Revised: 11/2009
 
Mission Hills S.A. de C.V.