COLGATE CAVITY PROTECTION- sodium fluoride gel, dentifrice 
Mission Hills S.A de C.V

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Colgate® Cavity Protection 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 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, sodium lauryl sulfate, flavor, PEG-12, cellulose gum, sodium saccharin, FD&C blue no. 1, FD&C yellow no. 5

Questions?

1-800-468-6502

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

PRINCIPAL DISPLAY PANEL - 119 g Tube Label

Cavity
Protection
Gel

Helps
Strengthen
Teeth

Colgate®
Fluoride Toothpaste

ADA
Accepted
American
Dental
Association

Toothpaste

NET WT
4.2 OZ
(119 g)

Principal Display Panel - 119 g Tube Label
COLGATE CAVITY PROTECTION 
sodium fluoride gel, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65954-591
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) 680 mg  in 1 g
WATER (UNII: 059QF0KO0R)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
Product Characteristics
ColorGREENScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65954-591-71119 g in 1 TUBE; Type 0: Not a Combination Product04/06/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH DRUGM02104/06/2014
Labeler - Mission Hills S.A de C.V (812312122)

Revised: 4/2019
Document Id: f75202bd-888d-47c5-9422-1965e66008b3
Set id: 821987f3-16b9-43da-ab83-3e73f531c677
Version: 4
Effective Time: 20190426
 
Mission Hills S.A de C.V