COLGATE  SPONGEBOB SQUAREPANTS- sodium fluoride gel, dentifrice 
Colgate-Palmolive Canada

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 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, tetrasodium pyrophosphate, sodium lauryl sulfate, flavor, sodium saccharin, mica, titanium dioxide, FD&C blue no. 1

Questions?

1-800-468-6502

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

PRINCIPAL DISPLAY PANEL - 24 g Tube Carton

Clinically Proven Cavity & Enamel Protection

Colgate®
Fluoride Toothpaste

ADA
Accepted
American
Dental
Association
®

NET WT 0.85 OZ (24 g)

nickelodeon

SpongeBob
SQUAREPANTS

BUBBLE FRUIT®FLAVOR

PRINCIPAL DISPLAY PANEL - 24 g Tube Carton
COLGATE   SPONGEBOB SQUAREPANTS
sodium fluoride gel, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51442-531
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O) Sodium Fluoride2.4 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
sorbitol (UNII: 506T60A25R)  
water (UNII: 059QF0KO0R)  
hydrated silica (UNII: Y6O7T4G8P9)  
Polyethylene Glycol 600 (UNII: NL4J9F21N9)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
sodium lauryl sulfate (UNII: 368GB5141J)  
Saccharin Sodium (UNII: SB8ZUX40TY)  
mica (UNII: V8A1AW0880)  
titanium dioxide (UNII: 15FIX9V2JP)  
FD&C Blue no. 1 (UNII: H3R47K3TBD)  
Product Characteristics
ColorBLUE (Pearlescent) Score    
ShapeSize
FlavorFRUITImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51442-531-2024 g in 1 TUBE; Type 0: Not a Combination Product03/16/201106/01/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35503/16/201106/01/2019
Labeler - Colgate-Palmolive Canada (259157246)

Revised: 9/2019
 
Colgate-Palmolive Canada