FDA Label for Colgate Total Whitening Gel

View Indications, Usage & Precautions

Colgate Total Whitening Gel Product Label

The following document was submitted to the FDA by the labeler of this product Team Technologies, Inc. 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 COMPANY
New York, NY 10022


Otc - Purpose



Active ingredientsPurpose
Sodium Fluoride 0.24% (0.14% w/v fluoride ion)Anticavity
Triclosan 0.30%Antigingivitis

Uses



aids in the prevention of:

  • cavities
  • plaque
  • gingivitis

Otc - Keep Out Of Reach Of Children



Keep out of the reach of children under 6 years of age.

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.


Ask A Dentist Before Use If You Have



  • bleeding or redness lasting more than 2 weeks
  • pain, swelling, pus, loose teeth, or more spacing between teeth
  • These may be signs of periodontitis, a serious form of gumdisease.


Directions



supervise children as necessary until capable of using without supervision.

adults and children 6 years of age and olderbrush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or a physician
children under 12 yearsinstruct in good brushing and rinsing habits (to minimize swallowing)
children under 6 yearsdo not use unless directed by a dentist or a physician

Antiplaque and antigingivitis use not proven in children.


Inactive Ingredients



Water, hydrated silica, glycerin, sorbitol, PVM/MA copolymer, sodium lauryl sulfate, cellulose gum, flavor, sodium hydroxide, carrageenan, propylene glycol, sodium saccharin, mica, titanium dioxide, FD&C blue no. 1


Questions Or Comments?



Call toll-free 1-800-468-6502


Principal Display Panel - 119 G Tube Carton



Colgate®
Anticavity Fluoride and Antigingivitis Toothpaste

Total®

ADA
Accepted
American
Dental
Association ®

WHITENING

NET WT 4.2 OZ (119 g)

HELPS REMOVE & PREVENT STAINS

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