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Colgate Total

Colgate Oral Pharmaceuticals, Inc.

Colgate Total FRESHMINT


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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

Colgate Total 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, propylene glycol, sorbitol, polysorbate 20, sodium benzoate, flavor, phosphoric acid, menthol, sodium saccharin, FD&C blue no. 1, FD&C yellow no. 5

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

Cetylpyridinium Chloride Antigingivitis / Antiplaque Mouthwash
ALCOHOL FREE

Significantly reduces
plaque

Helps reduce
gingivitis

Delivers long-lasting
fresh breath

12 HOUR PROTECTION
Against Plaque and Bacteria

CLINICALLY TESTED

FRESHMINT

30 FL OZ (1.87 PT) 887 mL

10001486

Colgate Total

Colgate Total

CETYLPYRIDINIUM CHLORIDE MOUTHWASH

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0126-0023
Route of Administration DENTAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
cetylpyridinium chloride 10.5 mg

Product Characteristics

Color
GREEN (transparent, no particulates)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0126-0023-08 236 in 1 BOTTLE
2 NDC:0126-0023-16 473 in 1 BOTTLE
3 NDC:0126-0023-14 887 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part356 2010-07-01


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Be sure to consult your doctor before taking any medication!
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