Colgate®

Colgate®
SPL v4
SPL
SPL Set ID 821987f3-16b9-43da-ab83-3e73f531c677
Route
DENTAL
Published
Effective Date 2019-04-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (1.1 mg)
Inactive Ingredients
Sorbitol Water Hydrated Silica Sodium Lauryl Sulfate Polyethylene Glycol 600 Carboxymethylcellulose Sodium, Unspecified Saccharin Sodium Fd&c Blue No. 1 Fd&c Yellow No. 5

Identifiers & Packaging

Pill Appearance
Color: green
Marketing Status
OTC MONOGRAPH DRUG Active Since 2014-04-06

Description

Drug Facts

Purpose

Anticavity


Medication Information

Purpose

Anticavity

Description

Drug Facts

Use

helps protect against cavities

Section 42229-5

Drug Facts

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
Questions?

1-800-468-6502

Active Ingredient

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

Inactive Ingredients

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

Principal Display Panel 119 G Tube Label

Cavity

Protection

Gel

Helps

Strengthen

Teeth

Colgate®

Fluoride Toothpaste

ADA

Accepted

American

Dental

Association

Toothpaste

NET WT

4.2 OZ

(119 g)


Structured Label Content

Use

helps protect against cavities

Section 42229-5 (42229-5)

Drug Facts

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
Questions?

1-800-468-6502

Active Ingredient (Active ingredient)

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

Inactive Ingredients (Inactive ingredients)

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

Principal Display Panel 119 G Tube Label (PRINCIPAL DISPLAY PANEL - 119 g Tube Label)

Cavity

Protection

Gel

Helps

Strengthen

Teeth

Colgate®

Fluoride Toothpaste

ADA

Accepted

American

Dental

Association

Toothpaste

NET WT

4.2 OZ

(119 g)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)