COLGATE TOTAL WHITENING- sodium fluoride and triclosan paste, dentifrice

Colgate Total Whitening by

Drug Labeling and Warnings

Colgate Total Whitening by is a Otc medication manufactured, distributed, or labeled by Colgate-Palmolive Company, Colgate-Palmolive. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
Sodium Fluoride 0.24% (0.14% 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 gumdisease.

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, cellulose gum, flavor, sodium hydroxide, carrageenan, propylene glycol, sodium saccharin, mica, titanium dioxide, FD&C blue no. 1

Questions or comments?

Call toll-free 1-800-468-6502

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 119 g Tube Carton

Colgate®
Anticavity Fluoride and Antigingivitis Toothpaste

Total®

ADA
Accepted
American
Dental
Association ®

WHITENING

NET WT 4.2 OZ (119 g)

HELPS REMOVE & PREVENT STAINS

• ✓ CAVITIES
• ✓ PLAQUE
• ✓ GINGIVITIS
• ✓ ENAMEL
• ✓ TARTAR
• ✓ BREATH
• ✓ WHITENS
  G l

INGREDIENTS AND APPEARANCE

COLGATE TOTAL WHITENING 
sodium fluoride and triclosan paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 35000-002
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	1.4 mg  in 1 g
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X)	TRICLOSAN	3 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
GLYCERIN (UNII: PDC6A3C0OX)
SORBITOL (UNII: 506T60A25R)
BUTYL ESTER OF METHYL VINYL ETHER/MALEIC ANHYDRIDE COPOLYMER (125000 MW) (UNII: 389H2R62BD)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
MICA (UNII: V8A1AW0880)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
CARRAGEENAN (UNII: 5C69YCD2YJ)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Product Characteristics
Color	BLUE, WHITE	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 35000-002-42	1 in 1 CARTON	09/20/2010	01/01/2022
1		119 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 35000-002-34	2 in 1 CARTON	09/20/2010	01/01/2022
2		170 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 35000-002-60	1 in 1 CARTON	09/20/2010	01/01/2022
3		170 g in 1 TUBE; Type 0: Not a Combination Product
4	NDC: 35000-002-71	1 in 1 CARTON	09/20/2010	02/23/2011
4		204 g in 1 TUBE; Type 0: Not a Combination Product
5	NDC: 35000-002-78	1 in 1 CARTON	09/20/2010	01/01/2022
5		221 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA020231	09/20/2010

Labeler - Colgate-Palmolive Company (001344381)

Establishment
Name	Address	ID/FEI	Business Operations
Colgate-Palmolive		785047999	MANUFACTURE(35000-002)