Crest ®

Crest ®
SPL v6
SPL
SPL Set ID 07ed767e-225c-e9c5-e063-6394a90af931
Route
DENTAL
Published
Effective Date 2023-11-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (1.6 mg)
Inactive Ingredients
Hydrated Silica Water Propylene Glycol Sodium Bicarbonate Sodium Pyrophosphate Sorbitol Polyethylene Glycol 600 Glycerin Sodium Hydroxide Sodium Lauryl Sulfate Saccharin Sodium Poloxamer 407 Xanthan Gum Carboxymethylcellulose Sodium Calcium Peroxide Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-11-13

Description

Drug Facts

Purpose

Anticavity toothpaste


Medication Information

Purpose

Anticavity toothpaste

Description

Drug Facts

Use

helps protect against cavities

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children under 6 yrs. 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 yrs. & older: brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist
    • do not swallow
    • to minimize swallowing use a pea-sized amount in children under 6
    • supervise children's brushing until good habits are established
  • children under 2 yrs.: ask a dentist
Questions?

1-800-492-7378

Active Ingredient

Sodium fluoride 0.243% (0.16% w/v fluoride ion)

Inactive Ingredients

glycerin, hydrated silica, water, propylene glycol, sodium bicarbonate, tetrasodium pyrophosphate, sorbitol, PEG-12, flavor, sodium hydroxide, sodium lauryl sulfate, sodium saccharin, poloxamer 407, xanthan gum, cellulose gum, calcium peroxide, titanium dioxide

Principal Display Panel 119 G Tube Carton

New Formula with 2X Peroxide

Crest Plus

Baking Soda & Peroxide

Whitening

With Tartar Protection

Fresh Mint

Net Wt 4.2 OZ (119g)


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 yrs. of age.If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Purpose

Anticavity toothpaste

Directions
  • adults and children 2 yrs. & older: brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist
    • do not swallow
    • to minimize swallowing use a pea-sized amount in children under 6
    • supervise children's brushing until good habits are established
  • children under 2 yrs.: ask a dentist
Questions?

1-800-492-7378

Active Ingredient (Active ingredient)

Sodium fluoride 0.243% (0.16% w/v fluoride ion)

Inactive Ingredients (Inactive ingredients)

glycerin, hydrated silica, water, propylene glycol, sodium bicarbonate, tetrasodium pyrophosphate, sorbitol, PEG-12, flavor, sodium hydroxide, sodium lauryl sulfate, sodium saccharin, poloxamer 407, xanthan gum, cellulose gum, calcium peroxide, titanium dioxide

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

New Formula with 2X Peroxide

Crest Plus

Baking Soda & Peroxide

Whitening

With Tartar Protection

Fresh Mint

Net Wt 4.2 OZ (119g)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)