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Colgate

Colgate-Palmolive Company

Colgate Anticavity Fluoride and Antigingivitis Toothpaste


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredients

Sodium fluoride 0.24% (0.14% 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

hydrated silica, water, 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 Mexico
www.colgate.com

PRINCIPAL DISPLAY PANEL - 5.8 OZ Tube

Helps Prevent Cavities • Gingivitis • Plaque

Colgate®
Anticavity Fluoride and Antigingivitis Toothpaste

Total®

ADVANCED CLEAN
PLUS
WHITENING

PASTE

EXTRA
CLEAN &
HEALTHY
MOUTH

ADA
ACCEPTED

American
Dental
Association ®

NET WT 5.8 OZ (164 g)

Colgate

PRINCIPAL DISPLAY PANEL - 5.8 OZ carton

Helps Prevent Cavities • Gingivitis • Plaque

Colgate®
Anticavity Fluoride and Antigingivitis Toothpaste

Total®

ADVANCED CLEAN
PLUS
WHITENING

PASTE

EXTRA
CLEAN &
HEALTHY
MOUTH

ADA
ACCEPTED

American
Dental
Association ®

NET WT 5.8 OZ (164 g)

Colgate

Colgate

SODIUM FLUORIDE and TRICLOSAN PASTE, DENTIFRICE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:65954-353
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
1 164 in 1 TUBE
2 NDC:65954-353-66 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020231 2009-07-07


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