Colgate ®

Colgate ®
SPL v3
SPL
SPL Set ID 34c56439-83d4-2808-e054-00144ff88e88
Route
DENTAL
Published
Effective Date 2015-02-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (1.4 mg)
Inactive Ingredients
Sorbitol Water Hydrated Silica Polyethylene Glycol 600 Sodium Lauryl Sulfate Carboxymethylcellulose Sodium Sodium Pyrophosphate Cocamidopropyl Betaine Saccharin Sodium Methylcellulose (100 Mpa.s) Fd&c Blue No. 1

Identifiers & Packaging

Pill Appearance
Color: blue
Marketing Status
OTC MONOGRAPH FINAL Active Since 2013-09-23

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, PEG-12, sodium lauryl sulfate, flavor, cellulose gum, tetrasodium pyrophosphate, cocamidopropyl betaine, sodium saccharin, methylcellulose, FD&C blue no. 1

Principal Display Panel 221 G Tube Carton

Colgate ®

Anticavity Fluoride Toothpaste

Bursting with Freshness

that Lasts for Hours!

NET WT 7.8 OZ (221 g)

WITH WHITENING

MaxFresh ®

WITH

MINI

BREATH STRIPS

COOL 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% (0.15% 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, methylcellulose, FD&C blue no. 1

Principal Display Panel 221 G Tube Carton (PRINCIPAL DISPLAY PANEL - 221 g Tube Carton)

Colgate ®

Anticavity Fluoride Toothpaste

Bursting with Freshness

that Lasts for Hours!

NET WT 7.8 OZ (221 g)

WITH WHITENING

MaxFresh ®

WITH

MINI

BREATH STRIPS

COOL MINT


Advanced Ingredient Data


Raw Label Data

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