Crest ®

Crest ®
SPL v8
SPL
SPL Set ID 5a1bb1fb-12a5-5fd1-e053-2991aa0a628b
Route
DENTAL
Published
Effective Date 2015-04-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (1.5 mg)
Inactive Ingredients
Water Hydrated Silica Sodium Lauryl Sulfate Sodium Phosphate Carboxymethylcellulose Sodium, Unspecified Form Saccharin Sodium Titanium Dioxide Sorbitol

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Completed Since 2015-03-09 Until 2022-02-01

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% (0.15% w/v fluoride ion)

Inactive Ingredients

sorbitol, water, hydrated silica, sodium lauryl sulfate, trisodium phosphate, flavor, sodium phosphate, cellulose gum, sodium saccharin, carbomer, titanium dioxide

Principal Display Panel 68 G Tube Carton

CLEANS & WHITENS TEETH*

Crest ®

FLUORIDE ANTICAVITY TOOTHPASTE

NET WT 2.4 OZ (68 g)

FRESH AND



WHITE

Peppermint



GLEEM™ Paste


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% (0.15% w/v fluoride ion)

Inactive Ingredients (Inactive ingredients)

sorbitol, water, hydrated silica, sodium lauryl sulfate, trisodium phosphate, flavor, sodium phosphate, cellulose gum, sodium saccharin, carbomer, titanium dioxide

Principal Display Panel 68 G Tube Carton (PRINCIPAL DISPLAY PANEL - 68 g Tube Carton)

CLEANS & WHITENS TEETH*

Crest ®

FLUORIDE ANTICAVITY TOOTHPASTE

NET WT 2.4 OZ (68 g)

FRESH AND



WHITE

Peppermint



GLEEM™ Paste


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)