Other
Drug Facts
Dist. by:
COLGATE-PALMOLIVE COMPANY
New York, NY 10022
Colgate Total Whitening Gel
FDA Label NDC 67659-310
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Team Technologies, Inc for the product Colgate Total Whitening Gel (NDC 67659-310). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, otc - purpose, uses, otc - keep out of reach of children, ask a dentist before use if you have, directions, inactive ingredients, questions or comments?, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
| 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
Otc - Keep Out Of Reach Of Children
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
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
Principal Display Panel (119 g Tube Carton)
* Please review the disclaimer below.
