Colgate® Cavity Protection Toothpaste - Great Regular Flavor

Drug Labeling and Warnings

Drug Details [pdf]

COLGATE CAVITY PROTECTION  GREAT REGULAR FLAVOR- sodium monofluorophosphate paste 
Colgate Oral Pharmaceuticals, Inc.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

----------

Colgate® Cavity Protection Toothpaste - Great Regular Flavor

Drug Facts

Active ingredient

Sodium monofluorophosphate 0.76% (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

dicalcium phosphate dihydrate, water, glycerin, sodium lauryl sulfate, cellulose gum, flavor, tetrasodium pyrophosphate, sodium saccharin

Questions?

1-800-468-6502

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

PRINCIPAL DISPLAY PANEL - 4.25 g Pouch Label

Colgate®
Fluoride Toothpaste

Cavity
Protection

Strengthens Teeth
with Active Fluoride
Great Regular Flavor

NET WT 0.15 OZ (4.25 g)

Tear Here

ADA
Accepted
American
Dental
Association ®

CP

Dist. by:
COLGATE-PALMOLIVE COMPANY
New York, NY 10022 MADE IN U.S.A.
www.colgate.com

0096
P10002190

Principal Display Panel - 4.25 g Pouch Label
COLGATE CAVITY PROTECTION   GREAT REGULAR FLAVOR
sodium monofluorophosphate paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 0126-0027
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium Monofluorophosphate (UNII: C810JCZ56Q) (Fluoride Ion - UNII:Q80VPU408O) Fluoride Ion11.4 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
Glycerin (UNII: PDC6A3C0OX)  
Sodium Lauryl Sulfate (UNII: 368GB5141J)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
Sodium Pyrophosphate (UNII: O352864B8Z)  
Saccharin Sodium (UNII: SB8ZUX40TY)  
Product Characteristics
ColorWHITE (clear) Score    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 0126-0027-444.25 g in 1 POUCH; Type 0: Not a Combination Product02/03/201208/01/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER02/03/201208/01/2019
Labeler - Colgate Oral Pharmaceuticals, Inc. (968801118)

Revised: 9/2019
Document Id: 0822a03c-2592-4cf9-b123-4d491ec10414
Set id: 10d420e3-11bf-437e-b869-907e8eafd47a
Version: 2
Effective Time: 20190909