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

Colgate Total 12 Hr Pro-Shield Spearmint Surge by

Drug Labeling and Warnings

Colgate Total 12 Hr Pro-Shield Spearmint Surge by is a Otc medication manufactured, distributed, or labeled by Colgate-Palmolive Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 1 L Bottle Label

ALCOHOL FREE

Colgate®
Antigingivitis
Antiplaque Mouthwash

Total™
WHOLE MOUTH HEALTH

12 HR PROTECTION*
EVEN
AFTER
EATING & DRINKING

Kills 99% of Germs on Contact

Significantly Reduces Plaque

Helps Prevent Gingivitis

10X LONGER LASTING COOL**

SPEARMINT

33.8 FL OZ (1.05 QT) 1L

P9930420

INGREDIENTS AND APPEARANCE

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

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

Inactive Ingredients
Ingredient Name	Strength
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)
LEVOMENTHOL (UNII: BZ1R15MTK7)
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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part356	09/01/2015

Labeler - Colgate-Palmolive Company (001344381)