Label: COLGATE TOTAL WHITENING- sodium fluoride and triclosan gel, dentifrice
- NDC Code(s): 65954-002-78
- Packager: Mission Hills, S.A. de C.V.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Updated September 3, 2010
If you are a consumer or patient please visit this version.
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
Active ingredients Purpose Sodium fluoride 0.24% (0.14% w/v fluoride ion) Anticavity Triclosan 0.30% Antigingivitis
aids in the prevention of:
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.
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.Close
- Inactive ingredients
water, hydrated silica, glycerin, sorbitol, PVM/MA copolymer, sodium lauryl sulfate, cellulose gum, flavor, sodium hydroxide, propylene glycol, carrageenan, sodium saccharin, mica, titanium dioxide, FD&C blue no.1Close
- Questions or comments?
Call toll-free 1-800-468-6502Close
- SPL UNCLASSIFIED SECTION
New York, NY 10022
- PRINCIPAL DISPLAY PANEL - 221 g Tube Carton
Helps Prevent Cavities • Gingivitis • Plaque
Anticavity Fluoride and Antigingivitis Toothpaste
NET WT 7.8 OZ (221 g)
Fights Tartar Buildup • Whitens Teeth
- INGREDIENTS AND APPEARANCE
COLGATE TOTAL WHITENING
sodium fluoride and triclosan gel, dentifrice
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:65954-002 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O) Sodium Fluoride 2.4 mg in 1 g Triclosan (UNII: 4NM5039Y5X) (Triclosan - UNII:4NM5039Y5X) Triclosan 3 mg in 1 g Product Characteristics Color WHITE, BLUE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65954-002-78 1 in 1 CARTON 1 221 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA020231 10/01/2009 Labeler - Mission Hills, S.A. de C.V. (812312122)