Drug Facts

Active ingredient

Cetylpyridinium chloride 0.075%

Purpose

Antigingivitis/Antiplaque

Uses

helps prevent and reduce plaque and gingivitis
helps control plaque bacteria that contribute to the development of gingivitis, an early form of gum disease, and bleeding gums

Warnings

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.

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.

Directions

adults and children 12 years of age and older	vigorously swish 20 mL 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

this rinse is not intended to replace brushing or flossing
store at 59°F to 77°F
keep from freezing

Inactive ingredients

water, glycerin, propylene glycol, sorbitol, poloxamer 407, flavor, potassium sorbate, sodium saccharin, citric acid, sucralose, FD&C green no. 3, FD&C yellow no. 6

Questions?

1-800-468-6502

Dist. by:
COLGATE-PALMOLIVE CO.
New York, NY 10022 U.S.A.

PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label

ALCOHOL FREE

Colgate®
Antigingivitis Antiplaque Mouthwash

Total

12 HR PROTECTION*
EVEN AFTER EATING AND DRINKING

ANTIBACTERIAL

Kills 99% of Germs on Contact
Significantly Reduces Plaque
Helps Prevent Gingivitis

10X LONGER LASTING COOL**

SPEARMINT

P80040924

16.9 FL OZ
(1.05 PT) 500 mL

PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label

COLGATE TOTAL 12 HR PRO-SHIELD SPEARMINT SURGE
cetylpyridinium chloride rinse

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:35000-731
Route of Administration	DENTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3)	CETYLPYRIDINIUM CHLORIDE	15 mg in 20 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SORBITOL (UNII: 506T60A25R)
POLOXAMER 407 (UNII: TUF2IVW3M2)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
SUCRALOSE (UNII: 96K6UQ3ZD4)
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)

Product Characteristics
Color	GREEN	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:35000-731-02	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/01/2015
2	NDC:35000-731-84	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/01/2015
3	NDC:35000-731-16	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/01/2015
4	NDC:35000-731-33	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/01/2015
5	NDC:35000-731-50	1500 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/01/2015

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH DRUG	505G(a)(3)	09/01/2015

Labeler - Colgate-Palmolive Company (001344381)

Colgate® Total™ 12 Hr Pro-Shield Spearmint Surge