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Drug Facts
Dist. by:
COLGATE-PALMOLIVE CO.
New York, NY 10022 U.S.A.
Colgate Total Active Prevention Gum Health Rinse
FDA Label NDC 35000-281
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 Active Prevention Gum Health (NDC 35000-281). 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, stop use and ask a dentist if, 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
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
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 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
Inactive Ingredients
Water, Glycerin, Propylene Glycol, Sorbitol, Poloxamer 407, Zinc Lactate, Flavor, Potassium Sorbate, Lactic Acid, Sodium Saccharin, Sucralose, Green 3.
Questions?
1-800-468-6502
Principal Display Panel - 500 Ml Bottle Label
ALCOHOL FREE
Colgate®
Antigingivitis Antiplaque Mouthwash
Total
ACTIVE PREVENTION
GUM HEALTH
Helps Prevent Gingivitis
24 HOUR ANTIBACTERIAL PROTECTION1
Fight Rood Cause2 of:
✓Gingivitis ✓Plaque ✓Tartar Buildup
ADA
Accepted
American
Dental
Association
CLINICALLY
PROVEN
16.9 FL OZ (1.05 PT) 500 mL
PS0073268
Principal Display Panel (500 mL Bottle Label)
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