Colgate
FDA Label NDC 67659-350

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 (NDC 67659-350). 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 active ingredients, purpose, uses, ask a dentist before use if you have, directions, inactive ingredients, questions or comments?, principal display panel - 226 g tube, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Active Ingredients

→ Purpose

→ Uses

→ Ask A Dentist Before Use If You Have

→ Directions

→ Inactive Ingredients

→ Questions Or Comments?

→ Principal Display Panel - 226 G Tube

→ Principal Display Panel - 226 G Carton

Active Ingredients

Sodium fluoride 0.24% (0.15% w/v fluoride ion)

Triclosan 0.30%

Purpose

Anticavity

Antigingivitis

Uses

aids in the prevention of:

cavities
plaque
gingivitis

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, PVM/MA copolymer, sodium lauryl sulfate, flavor, cellulose gum, sodium hydroxide, propylene glycol, carrageenan, sodium saccharin, titanium dioxide