Colgate®

Colgate®
SPL v4
SPL
SPL Set ID 30e98e1a-ac3f-40dc-9fd2-d2fba1314527
Route
DENTAL
Published
Effective Date 2020-04-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (1 mg)
Inactive Ingredients
Water Hydrated Silica Sorbitol Calcium Pyrophosphate Glycerin Polyethylene Glycol 600 Sodium Tripolyphosphate Anhydrous Potassium Pyrophosphate Sodium Lauryl Sulfate Carboxymethylcellulose Sodium, Unspecified Saccharin Sodium Activated Charcoal Xanthan Gum Cocamidopropyl Betaine Fd&c Blue No. 1 Fd&c Red No. 40 Fd&c Yellow No. 5

Identifiers & Packaging

Pill Appearance
Color: gray
Marketing Status
OTC MONOGRAPH DRUG Completed Since 2018-04-09 Until 2020-12-31

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 monofluorophosphate 0.76% (0.10% w/v fluoride ion)

Inactive Ingredients

water, hydrated silica, sorbitol, calcium pyrophosphate, glycerin, PEG-12, pentasodium triphosphate, tetrapotassium pyrophosphate, flavor, sodium lauryl sulfate, cellulose gum, sodium saccharin, charcoal powder, xanthan gum, cocamidopropyl betaine, blue 1, red 40, yellow 5

Principal Display Panel 130 G Tube Carton

Colgate®

Anticavity Fluoride Toothpaste

REVITALIZING

WHITE

whitening toothpaste

with

activated charcoal

NET WT 4.6 OZ (130g)

FRESH 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 monofluorophosphate 0.76% (0.10% w/v fluoride ion)

Inactive Ingredients (Inactive ingredients)

water, hydrated silica, sorbitol, calcium pyrophosphate, glycerin, PEG-12, pentasodium triphosphate, tetrapotassium pyrophosphate, flavor, sodium lauryl sulfate, cellulose gum, sodium saccharin, charcoal powder, xanthan gum, cocamidopropyl betaine, blue 1, red 40, yellow 5

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

Colgate®

Anticavity Fluoride Toothpaste

REVITALIZING

WHITE

whitening toothpaste

with

activated charcoal

NET WT 4.6 OZ (130g)

FRESH MINT


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)