Crest®

Crest®
SPL v10
SPL
SPL Set ID 7d51c67b-7409-e5a7-e053-2a91aa0a81fa
Route
DENTAL
Published
Effective Date 2018-12-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (1.5 mg)
Inactive Ingredients
Carboxypolymethylene Saccharin Sodium Sorbitol Water Hydrated Silica Sodium Lauryl Sulfate Sodium Phosphate Carboxymethylcellulose Sodium Sodium Phosphate, Tribasic, Anhydrous Fd&c Red No. 40

Identifiers & Packaging

Pill Appearance
Color: pink
Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-12-18

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.

Section 50567-7

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

Directions
  • twist off cap to remove foil seal
  • 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, sodium phosphate, cellulose gum, flavor, sodium saccharin, carbomer, red 40

Principal Display Panel 119 G Tube

3+ YRS



Crest ®

FLUORIDE ANTICAVITY TOOTHPASTE

Disney

Junior

MICKEY

STRAWBERRY

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 yrs. of age.

Section 50567-7 (50567-7)

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

Purpose

Anticavity toothpaste

Directions
  • twist off cap to remove foil seal
  • 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, sodium phosphate, cellulose gum, flavor, sodium saccharin, carbomer, red 40

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

3+ YRS



Crest ®

FLUORIDE ANTICAVITY TOOTHPASTE

Disney

Junior

MICKEY

STRAWBERRY

NET WT 4.2 OZ (119 g)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)