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Colgate Cavity Protection by Mission Hills S.A de C.V

Medically reviewed on Jun 5, 2018

Dosage form: gel, dentifrice
Ingredients: SODIUM FLUORIDE 1.1mg in 1g
Labeler: Mission Hills S.A de C.V
NDC Code: 65954-591

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® 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)

COLGATE CAVITY PROTECTION 
sodium fluoride gel, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65954-591
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION1.1 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
SORBITOL680 mg  in 1 g
WATER 
HYDRATED SILICA 
SODIUM LAURYL SULFATE 
POLYETHYLENE GLYCOL 600 
CARBOXYMETHYLCELLULOSE SODIUM 
SACCHARIN SODIUM 
FD&C BLUE NO. 1 
FD&C YELLOW NO. 5 
Product Characteristics
ColorGREENScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:65954-591-71119 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35504/06/2014
Labeler - Mission Hills S.A de C.V (812312122)

 
Mission Hills S.A de C.V

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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