Colgate®

Colgate®
SPL v7
SPL
SPL Set ID 5a5474c7-d57c-4249-bbb2-1c3ce9edaabe
Route
DENTAL
Published
Effective Date 2021-11-08
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 Polyethylene Glycol 600 Poloxamer 407 Sodium Lauryl Sulfate Xanthan Gum Cocamidopropyl Betaine Sodium Pyrophosphate Mica Titanium Dioxide Saccharin Sodium Methylcellulose (400 Mpa.s) Fd&c Blue No. 1

Identifiers & Packaging

Pill Appearance
Color: blue
Marketing Status
OTC MONOGRAPH DRUG Completed Since 2011-03-18 Until 2013-12-31

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% (0.14% w/v fluoride ion)

Inactive Ingredients

water, sorbitol, hydrated silica, PEG-12, poloxamer 407, sodium lauryl sulfate, flavor, xanthan gum, cocamidopropyl betaine, tetrasodium pyrophosphate, sodium saccharin, methylcellulose, mica, titanium dioxide, FD&C blue no. 1

Principal Display Panel 170 G Tube Carton

Colgate®

Anticavity Fluoride Toothpaste

10X

LONGER

LASTING

COOL

MaxClean

WITH WHITENING

SMART FOAM®

CLEANS TOUGH TO REACH SPACES

Recyclable

Tube

NET WT 6.0 OZ (170 g)

EFFERVESCENT MINT


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% (0.14% w/v fluoride ion)

Inactive Ingredients (Inactive ingredients)

water, sorbitol, hydrated silica, PEG-12, poloxamer 407, sodium lauryl sulfate, flavor, xanthan gum, cocamidopropyl betaine, tetrasodium pyrophosphate, sodium saccharin, methylcellulose, mica, titanium dioxide, FD&C blue no. 1

Principal Display Panel 170 G Tube Carton (PRINCIPAL DISPLAY PANEL - 170 g Tube Carton)

Colgate®

Anticavity Fluoride Toothpaste

10X

LONGER

LASTING

COOL

MaxClean

WITH WHITENING

SMART FOAM®

CLEANS TOUGH TO REACH SPACES

Recyclable

Tube

NET WT 6.0 OZ (170 g)

EFFERVESCENT MINT


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)