Colgate Total 12 Hr Pro-shield Spearmint Surge Rinse
FDA Label NDC 35000-731

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Colgate-palmolive Company for the product Colgate Total 12 Hr Pro-shield Spearmint Surge (NDC 35000-731). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient, purpose, uses, otc - stop use, otc - keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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

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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

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Principal Display Panel (1 L Bottle Label)

* Please review the disclaimer below.