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SPL v3
SPL
SPL Set ID 78e71337-060c-4d40-8eed-cff3f54e097c
Route
DENTAL
Published
Effective Date 2024-09-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (1.1 mg)
Inactive Ingredients
Water Hydrated Silica Sorbitol Potassium Hydroxide Polyethylene Glycol 600 Phosphoric Acid Sodium Pyrophosphate Sodium Lauryl Sulfate Carboxymethylcellulose Sodium, Unspecified Cocamidopropyl Betaine Saccharin Sodium Xanthan Gum Benzyl Alcohol D&c Red No. 33 Fd&c Blue No. 1 Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Color: white Color: red Color: blue
Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-10-01

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 Contol Center right away.

Directions
adults and children 2 years of age and older brush teeth throughly, 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

Water, Sorbitol, Hydrated Silica, PEG-12, Sodium Lauryl Sulfate, Flavor, Cellulose Gum, Potassium Hydroxide, Tetrasodium Pyrophosphate, Phosphoric Acid, Cocamidopropyl Betaine, Benzyl Alcohol, Sodium Saccharin, Blue 1, Red 33, Titanium Dioxide.

Principal Display Panel 119 G Tube Carton

Colgate®

Anticavity Fluoride Toothpaste

ENAMEL SAFE

Removes 95% of

Daily Surface Stains*

Fresh Mint Paste

For a Brighter Smile

OPTIC

WHITE®

PURPLE

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 Contol Center right away.

Purpose

Anticavity

Directions
adults and children 2 years of age and older brush teeth throughly, 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

Water, Sorbitol, Hydrated Silica, PEG-12, Sodium Lauryl Sulfate, Flavor, Cellulose Gum, Potassium Hydroxide, Tetrasodium Pyrophosphate, Phosphoric Acid, Cocamidopropyl Betaine, Benzyl Alcohol, Sodium Saccharin, Blue 1, Red 33, Titanium Dioxide.

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

Colgate®

Anticavity Fluoride Toothpaste

ENAMEL SAFE

Removes 95% of

Daily Surface Stains*

Fresh Mint Paste

For a Brighter Smile

OPTIC

WHITE®

PURPLE

NET WT

4.2 OZ (119 g)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)