Colgate® Total™ GENTLE CARE

Drug Labeling and Warnings

Drug Details [pdf]

COLGATE TOTAL  GENTLE CARE SOFTMINT- cetylpyridinium chloride mouthwash 
Colgate Oral Pharmaceuticals, Inc.

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®
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 Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0126-0025
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3)	CETYLPYRIDINIUM CHLORIDE	10.5 mg  in 20 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0126-0025-08	236 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/01/2010	08/01/2019
2	NDC: 0126-0025-16	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/01/2010	08/01/2019
3	NDC: 0126-0025-14	887 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/01/2010	08/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	07/01/2010	08/01/2019

Labeler - Colgate Oral Pharmaceuticals, Inc. (968801118)

Revised: 9/2019

Document Id: 2887fcb7-ac1c-4a55-b9a0-43c292cfb7a1

34390-5

Set id: 1f89a832-0934-495f-9e28-c5327582ea4a

Version: 2

Effective Time: 20190910

 

Colgate Oral Pharmaceuticals, Inc.