FDA Label for Colgate Total Whitening Charcoal

View Indications, Usage & Precautions

Colgate Total Whitening Charcoal 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



Stannous Fluoride 0.454% (0.15% w/v fluoride ion)


Purposes



Anticavity, Antigingivitis, Antisensitivity


Uses



  • aids in the prevention of cavities
  • helps prevent gingivitis
  • helps interfere with harmful effects of plaque associated with gingivitis
  • builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact

Otc - When Using



When using this product for sensitivity, do not use longer than 4 weeks unless recommended by a dentist.


Otc - Stop Use



Stop use and ask a dentist if the sensititvity problem persists or worsens.

Sensitive teeth may indicate a serious problem that may need prompt care by a dentist.


Otc - Keep Out Of Reach Of Children



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


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 of periodontitis, a serious form of gum disease.

Directions



  • adults and children 12 years of age and older: apply at least a 1-inch strip of the product onto a soft bristled toothbrush. Brush teeth thoroughly for at least 1 minute twice a day (morning and evening) or as recommended by a dentist.
    Make sure to brush all sensitive areas of the teeth.
  • do not swallow.
  • children under 12 years of age: consult a dentist.

Other Information



  • products containing stannous fluoride may produce surface staining of the teeth. Adequate toothbrushing may prevent these stains which are not harmful or permanent and may be removed by your dentist.
  • this Colgate product is specially formulated to help prevent staining.

Inactive Ingredients



Water, Sorbitol, Hydrated Silica, Glycerin, PEG-12, Tetrasodium Pyrophosphate, Flavor, Sodium Lauryl Sulfate, Zinc Phosphate, Cellulose Gum, Sodium Citrate, Microcrystalline Cellulose, Sodium Saccharin, Cocamidopropyl Betaine, Xanthan Gum, Citric Acid, Charcoal Powder, Sucralose, Titanium Dioxide.


Questions?



1-800-468-6502


Principal Display Panel - 136 G Tube Carton



Colgate®
Anticavity, Antigingivitis and Antisensitivity Toothpaste

Total
WHOLE MOUTH HEALTH

12
HR

ANTIBACTERIAL
PROTECTION*

STANNOUS FLUORIDE

WHITENING
+ CHARCOAL

✓CAVITIES ✓PLAQUE ✓GINGIVITIS ✓ENAMEL ✓TARTAR ✓FRESH BREATH
✓WHITENS ✓SENSITIVITY RELIEF ✓DEEP CLEAN ✓ODOR NEUTRALIZATION

FIGHTS BACTERIA ON TEETH, TONGUE, CHEEKS AND GUMS

NET WT 4.8 OZ (136 g)

Paste


* Please review the disclaimer below.