FDA Label for Colgate Total 12 Hr Pro-shield Spearmint Surge

View Indications, Usage & Precautions

Colgate Total 12 Hr Pro-shield Spearmint Surge Product Label

The following document was submitted to the FDA by the labeler of this product Colgate-palmolive Company. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Other



Drug Facts

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


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

Otc - Stop Use



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.

Otc - Keep Out Of Reach Of Children



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 oldervigorously 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 agesupervise use
children under 6 years of agedo 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


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


* Please review the disclaimer below.