Colgate Total Gentle Care Softmint

Dosage form: mouthwash
Ingredients: CETYLPYRIDINIUM CHLORIDE 10.5mg in 20mL
Labeler: Colgate Oral Pharmaceuticals, Inc.
NDC Code: 0126-0025

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®
Total
GENTLE CARE

Drug Facts

Active ingredient (in each 20 mL)

cetylpyridinium chloride (0.05% w/w)

Purpose

Antigingivitis/Antiplaque

Use

helps control plaque that leads to gingivitis

Warnings

Keep out of reach of children under 6 years of age. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Stop use and ask a dentist if

  • gingivitis, bleeding, or redness persists for more than 2 weeks
  • you have painful or swollen gums, pus from the gum line, loose teeth, or increasing spacing between the teeth

These may be signs or symptoms of periodontitis, a serious form of gum disease.

Directions
adults and children
12 years of age and older
  • vigorously swish 20 mL (4 teaspoons) of rinse between your teeth twice a day for 30 seconds and then spit out
  • do not swallow the rinse
children 6 years to under
12 years of age
  • supervise use
children under 6 years of age
  • do not use

Other information
  • store at controlled room temperature 20-25° C (68-77° F)
  • this rinse is not intended to replace brushing or flossing

Inactive ingredients

water, glycerin, sorbitol, propylene glycol, polysorbate 20, sodium phosphate monobasic, potassium citrate, sodium benzoate, flavor, sodium phosphate dibasic, sodium saccharin

Questions or comments?

Call toll-free 1-800-468-6502

Dist. by:
COLGATE-PALMOLIVE COMPANY
New York, NY 10022 Made in U.S.A.

PRINCIPAL DISPLAY PANEL - 887 mL Bottle Label

Colgate®

Total

GENTLE CARE
Cetylpyridinium Chloride Antigingivitis / Antiplaque Mouthwash
ALCOHOL FREE

Gentle care for a
sensitive mouth

Significantly reduces
plaque

Helps reduce
gingivitis

Delivers long-lasting
fresh breath

12 HOUR PROTECTION
Against Plaque and Bacteria

CLINICALLY TESTED

SOFTMINT

30 FL OZ (1.87 PT) 887 mL

10001490

COLGATE TOTAL   GENTLE CARE SOFTMINT
cetylpyridinium chloride mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0126-0025
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETYLPYRIDINIUM CHLORIDE (CETYLPYRIDINIUM) CETYLPYRIDINIUM CHLORIDE10.5 mg  in 20 mL
Packaging
#Item CodePackage Description
1NDC:0126-0025-08236 mL in 1 BOTTLE
2NDC:0126-0025-16473 mL in 1 BOTTLE
3NDC:0126-0025-14887 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35607/01/2010
Labeler - Colgate Oral Pharmaceuticals, Inc. (055002195)

Revised: 07/2010
 
Colgate Oral Pharmaceuticals, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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