Colgate® Total® Advanced Fresh plus Whitening

Drug Details [pdf]

COLGATE TOTAL ADVANCED FRESH PLUS WHITENING- sodium fluoride and triclosan paste, dentifrice
Colgate-Palmolive

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Colgate® Total® Advanced Fresh plus Whitening

Drug Facts

Active ingredients	Purpose
Sodium fluoride 0.24% (0.15% w/v fluoride ion)	Anticavity
Triclosan 0.30%	Antigingivitis

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

PRINCIPAL DISPLAY PANEL - 21.2 g Tube Carton

COLGATE TOTAL ADVANCED FRESH PLUS WHITENING
sodium fluoride and triclosan paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 35000-570
Route of Administration	DENTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O)	Fluoride Ion	1.5 mg in 1 g
Triclosan (UNII: 4NM5039Y5X) (Triclosan - UNII:4NM5039Y5X)	Triclosan	3 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
Water (UNII: 059QF0KO0R)
Sorbitol (UNII: 506T60A25R)
Butyl Ester Of Methyl Vinyl Ether/Maleic Anhydride Copolymer (125000 MW) (UNII: 389H2R62BD)
Sodium Lauryl Sulfate (UNII: 368GB5141J)
Carboxymethylcellulose Sodium, unspecified form (UNII: K679OBS311)
Sodium Hydroxide (UNII: 55X04QC32I)
Propylene Glycol (UNII: 6DC9Q167V3)
Carrageenan (UNII: 5C69YCD2YJ)
FD&C blue No. 1 (UNII: H3R47K3TBD)
D&C yellow No. 10 (UNII: 35SW5USQ3G)
Saccharin Sodium (UNII: SB8ZUX40TY)
Hydrated Silica (UNII: Y6O7T4G8P9)
Mica (UNII: V8A1AW0880)

Product Characteristics
Color	GREEN	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 35000-570-16	1 in 1 CARTON	08/12/2011	08/01/2019
1		21.2 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 35000-570-69	1 in 1 CARTON	08/12/2011	08/01/2019
2		113 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 35000-570-66	1 in 1 CARTON	08/12/2011	08/01/2019
3		164 g in 1 TUBE; Type 0: Not a Combination Product
4	NDC: 35000-570-48	1 in 1 CARTON	08/12/2011	08/01/2019
4		226 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
NDA	NDA020231	08/12/2011	08/01/2019

Labeler - Colgate-Palmolive (068693167)

Revised: 9/2019

Document Id: 60be9e53-a4c9-47b3-b760-0005ea3c774d

Set id: 326cec20-b0e0-42c8-b026-80bcc996f86d

Version: 3

Effective Time: 20190906

Colgate-Palmolive