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Colgate

Colgate-Palmolive

Colgate Anticavity Fluoride and Antigingivitis Toothpaste


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredients

Sodium fluoride 0.24% (0.15% w/v fluoride ion)

Triclosan 0.30%

Purpose

Anticavity

Antigingivitis

Colgate Uses

aids in the prevention of:

  • cavities
  • plaque
  • gingivitis

Warnings

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 gum disease.

Directions

supervise children as necessary until capable of using without supervision.

adults and children 6 years of age and older brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or a physician
children under 12 years instruct in good brushing and rinsing habits
(to minimize swallowing)
children under 6 years do 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, flavor, cellulose gum, sodium hydroxide, propylene glycol, carrageenan, sodium saccharin, titanium dioxide

Questions or comments?

Call toll-free 1-800-468-6502

Dist. by:
COLGATE-PALMOLIVE COMPANY
New York, NY 10022  Made in U.S.A.
www.colgatetotal.com

PRINCIPAL DISPLAY PANEL - 226 g Tube

Helps Prevent Cavities • Gingivitis • Plaque

Colgate®
Total®
Anticavity Fluoride and Antigingivitis Toothpaste

ADVANCED WHITENING
PASTE

HELPS
REMOVE &
PREVENT
STAINS*

ADA
ACCEPTED

American
Dental
Association ®

NET WT 8.0 OZ (226 g)

Colgate

PRINCIPAL DISPLAY PANEL - 226 g carton

Helps Prevent Cavities • Gingivitis • Plaque

Colgate®
Total®
Anticavity Fluoride and Antigingivitis Toothpaste

ADVANCED WHITENING
PASTE

HELPS
REMOVE &
PREVENT
STAINS*

ADA
ACCEPTED

American
Dental
Association ®

NET WT 8.0 OZ (226 g)

Colgate

Colgate

Sodium Fluoride and Triclosan PASTE, DENTIFRICE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:35000-364
Route of Administration DENTAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE FLUORIDE ION 2.4 mg
TRICLOSAN TRICLOSAN 3 mg

Product Characteristics

Color
WHITE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 226 in 1 TUBE
2 NDC:35000-364-48 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020231 2008-08-09


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