Colgate Total Enamel Strength Paste, Dentifrice
FDA Label NDC 35000-284

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 Enamel Strength (NDC 35000-284). 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, purposes, uses, otc - when using, otc - stop use, otc - keep out of reach of children, stop use and ask a dentist if, 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 COMPANY
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 sensitivity 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, Flavor, Sodium Lauryl Sulfate, Tetrasodium Pyrophosphate, Cellulose Gum, Potassium Nitrate, Sodium Saccharin, Xanthan Gum, Cocamidopropyl Betaine, Titanium Dioxide.

Questions?

1-800-468-6502

Principal Display Panel - 85 G Tube Carton

Colgate®
Anticavity, Antigingivitis and Antisensitivity Toothpaste

Total
ACTIVE PREVENTION

NET WT 3.0 OZ (85 g)

WHITENING
PASTE

CLINICALLY
PROVEN

ANTIBACTERIAL
24
HOUR1

✓ Gingivitis ✓ Plaque ✓ Tartar ✓ Sensitivity
✓ Weak Enamel ✓ Stains ✓ Bad Breath ✓ Cavities

Enamel
Strength

Reduces Sensitivity
and Remineralizes
to Strengthen
Weak Enamel

Principal Display Panel (85 g Tube Carton)

Principal Display Panel (85 g Tube Carton)

* Please review the disclaimer below.