COLGATE LUMINOUS CRYSTAL FLUORIDE- sodium fluoride 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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Colgate®
Fluoride Toothpaste

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 
sodium fluoride gel, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65954-022
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.1 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
SORBITOL (UNII: 506T60A25R) 564.38 mg  in 1 g
WATER (UNII: 059QF0KO0R)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
MICA (UNII: V8A1AW0880)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Product Characteristics
ColorBLUE (sky blue) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65954-022-691 in 1 CARTON
1113 g in 1 TUBE
2NDC:65954-022-641 in 1 CARTON
2181 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: 4/2013
Document Id: 3c1317de-fd30-4a2e-97fd-0f96cd4b27b8
Set id: 560d75e7-8b91-4501-a10a-71b3f8158848
Version: 2
Effective Time: 20130429
 
Mission Hills S.A. de C.V.