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Colgate

Colgate-Palmolive

Colgate Total Advanced Fresh plus Whitening


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Purpose

Active ingredients Purpose
Sodium fluoride 0.24% (0.15% w/v fluoride ion) Anticavity
Triclosan 0.30% 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, flavor, PVM/MA copolymer, sodium lauryl sulfate, cellulose gum, sodium hydroxide, propylene glycol, carrageenan, sodium saccharin, mica, titanium dioxide, FD&C blue no. 1, D&C yellow no. 10

Questions or comments?

Call toll-free 1-800-468-6502

Dist. by:
COLGATE-PALMOLIVE COMPANY
New York, NY 10022

PRINCIPAL DISPLAY PANEL - 21.2 g Tube Carton

NEW

Colgate ®
Anticavity Fluoride and Antigingivitis Toothpaste

Total ®

ADA
Accepted

American
Dental
Association ®

FRESH+WHITENING FRESHENS BREATH FOR 12 HOURS & WHITENS TEETH
ADVANCED

NET WT 0.75 OZ (21.2 g)
Helps Prevent: Cavities • Gingivitis • Plaque | Fights Tartar • Freshens Breath • Whitens
Fresh Gel

Colgate

Colgate

Sodium Fluoride and Triclosan PASTE, DENTIFRICE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:35000-570
Route of Administration DENTAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE FLUORIDE ION 1.5 mg
TRICLOSAN TRICLOSAN 3 mg

Inactive Ingredients

Ingredient Name Strength
water
sorbitol
BUTYL ESTER OF METHYL VINYL ETHER/MALEIC ANHYDRIDE COPOLYMER (125000 MW)
SODIUM LAURYL SULFATE
CARBOXYMETHYLCELLULOSE SODIUM
SODIUM HYDROXIDE
propylene glycol
CARRAGEENAN
FD&C BLUE NO. 1
D&C YELLOW NO. 10
saccharin sodium
HYDRATED SILICA
MICA

Product Characteristics

Color
GREEN

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 21.2 in 1 TUBE
2 113 in 1 TUBE
3 164 in 1 TUBE
4 226 in 1 TUBE
5 NDC:35000-570-48 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020231 2011-08-12


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