Colgate®

Colgate®
SPL v2
SPL
SPL Set ID 84da9056-5806-49b2-98aa-f104539376b2
Route
DENTAL
Published
Effective Date 2010-11-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (2.4 mg)
Inactive Ingredients
Sorbitol Water Hydrated Silica Polyethylene Glycol Sodium Lauryl Sulfate Carboxymethylcellulose Sodium Sodium Pyrophosphate Cocamidopropyl Betaine Saccharin Sodium Titanium Dioxide Fd&c Blue No. 1 Fd&c Yellow No. 5

Identifiers & Packaging

Pill Appearance
Color: blue Color: white Color: green
Marketing Status
OTC MONOGRAPH FINAL Active Since 2010-11-17

Description

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

Purpose

Anticavity


Medication Information

Purpose

Anticavity

Description

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

Use

helps protect against cavities

Section 42229-5

Dist. by:

COLGATE-PALMOLIVE COMPANY

New York, NY 10022

Made in Canada

www.colgate.com

Section 50565-1

Keep out of 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.

Directions
  • Adults and children 2 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 physician.
  • Children 2 to 6 years: Use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing).
  • Children under 2 years: Ask a dentist or physician.
Active Ingredient

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

Inactive Ingredients

sorbitol, water, hydrated silica, PEG-12, sodium lauryl sulfate, flavor, cellulose gum, tetrasodium pyrophosphate, cocamidopropyl betaine, sodium saccharin, titanium dioxide, FD&C blue no. 1, FD&C yellow no. 5

Questions Or Comments?

1-800-468-6502



Principal Display Panel 130 G Tube

Colgate ®

Fluoride Toothpaste

NET WT 4.6 OZ (130 g)

Triple

Action

Original Mint

Cavity Protection

1

Whiter Teeth

2

Fresh Breath

3


Structured Label Content

Use

helps protect against cavities

Section 42229-5 (42229-5)

Dist. by:

COLGATE-PALMOLIVE COMPANY

New York, NY 10022

Made in Canada

www.colgate.com

Section 50565-1 (50565-1)

Keep out of 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.

Purpose

Anticavity

Directions
  • Adults and children 2 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 physician.
  • Children 2 to 6 years: Use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing).
  • Children under 2 years: Ask a dentist or physician.
Active Ingredient (Active ingredient)

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

Inactive Ingredients (Inactive ingredients)

sorbitol, water, hydrated silica, PEG-12, sodium lauryl sulfate, flavor, cellulose gum, tetrasodium pyrophosphate, cocamidopropyl betaine, sodium saccharin, titanium dioxide, FD&C blue no. 1, FD&C yellow no. 5

Questions Or Comments? (Questions or comments?)

1-800-468-6502



Principal Display Panel 130 G Tube (PRINCIPAL DISPLAY PANEL - 130 g Tube)

Colgate ®

Fluoride Toothpaste

NET WT 4.6 OZ (130 g)

Triple

Action

Original Mint

Cavity Protection

1

Whiter Teeth

2

Fresh Breath

3


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)