Crest®

Crest®
SPL v17
SPL
SPL Set ID 960e0e3e-10e8-7426-e053-2a95a90a5b02
Route
DENTAL
Published
Effective Date 2019-10-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (1.5 mg)
Inactive Ingredients
Sodium Hydroxide Saccharin Sodium Glycerin Poloxamer 407 Sodium Acid Pyrophosphate Sodium Lauryl Sulfate Alcohol Xanthan Gum Carboxypolymethylene Polysorbate 80 Sodium Benzoate Cetylpyridinium Chloride Sorbitol Benzoic Acid Fd&c Blue No. 1 Water Hydrated Silica Titanium Dioxide Fd&c Yellow No. 5

Identifiers & Packaging

Pill Appearance
Color: green
Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-09-09 Until 2024-12-31

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, disodium pyrophosphate, flavor, sodium lauryl sulfate, sodium hydroxide, alcohol (0.7%), xanthan gum, sodium saccharin, glycerin, carbomer, poloxamer 407, polysorbate 80, sodium benzoate, cetylpyridinium chloride, benzoic acid, titanium dioxide, blue 1, yellow 5

Principal Display Panel 153 G Carton

Crest ®

plus™

NET WT 5.4 OZ (153 g)

FLUORIDE TOOTHPASTE



+ WHITENING

scope

OUTLAST
®

FEEL FRESH UP TO 7X LONGER

long lasting 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 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, disodium pyrophosphate, flavor, sodium lauryl sulfate, sodium hydroxide, alcohol (0.7%), xanthan gum, sodium saccharin, glycerin, carbomer, poloxamer 407, polysorbate 80, sodium benzoate, cetylpyridinium chloride, benzoic acid, titanium dioxide, blue 1, yellow 5

Principal Display Panel 153 G Carton (PRINCIPAL DISPLAY PANEL - 153 g Carton)

Crest ®

plus™

NET WT 5.4 OZ (153 g)

FLUORIDE TOOTHPASTE



+ WHITENING

scope

OUTLAST
®

FEEL FRESH UP TO 7X LONGER

long lasting mint


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)