Crest ®

Crest ®
SPL v10
SPL
SPL Set ID 2c1c5563-0b7e-4c7c-b49f-3d72e078cd28
Route
ORAL
Published
Effective Date 2015-04-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.1 mg)
Inactive Ingredients
Water Glycerin Hydrogen Peroxide Poloxamer 407 Polysorbate 80 Saccharin Sodium Sucralose Phosphoric Acid Sodium Phosphate, Dibasic, Anhydrous

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2015-07-20

Description

Drug Facts

Purpose

Anticavity


Medication Information

Purpose

Anticavity

Description

Drug Facts

Use

Aids in the prevention of dental cavities

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions
  • Adults and children 12 years & older:
    • Use twice a day after brushing your teeth with a toothpaste.
    • Vigorously swish 10 mL (2 teaspoonfuls) of rinse between your teeth for 1 minute and then spit out.
    • Do not swallow the rinse.
    • Do not eat or drink for 30 minutes after rinsing.
    • Instruct children under 12 years of age in good rinsing habits (to minimize swallowing).
    • Supervise children as necessary until capable of using without supervision.
  • Children under 12 years of age: consult a dentist or doctor.
Questions?

1-800-285-9139

Active Ingredient

Sodium Fluoride 0.02% (0.01% w/v fluoride ion)

Inactive Ingredients

water, glycerin, hydrogen peroxide, poloxamer 407, flavor, polysorbate 80, sodium saccharin, sucralose, phosphoric acid, disodium phosphate

Principal Display Panel 473 Ml Bottle Label

+FLUORIDE

CREST

PRO-HEALTH

ADVANCED

ANTICAVITY FLUORIDE RINSE

EXTRA WHITENING

ALCOHOL FREE

IMPORTANT:

Read directions

for proper use.

KILLS BAD BREATH GERMS

WHITER SMILE** IN 7 DAYS

HELPS PREVENT CAVITIES

STRENGTHENS ENAMEL

FRESHENS BREATH

473mL

(16 FL OZ)


Structured Label Content

Use

Aids in the prevention of dental cavities

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Purpose

Anticavity

Directions
  • Adults and children 12 years & older:
    • Use twice a day after brushing your teeth with a toothpaste.
    • Vigorously swish 10 mL (2 teaspoonfuls) of rinse between your teeth for 1 minute and then spit out.
    • Do not swallow the rinse.
    • Do not eat or drink for 30 minutes after rinsing.
    • Instruct children under 12 years of age in good rinsing habits (to minimize swallowing).
    • Supervise children as necessary until capable of using without supervision.
  • Children under 12 years of age: consult a dentist or doctor.
Questions?

1-800-285-9139

Active Ingredient (Active ingredient)

Sodium Fluoride 0.02% (0.01% w/v fluoride ion)

Inactive Ingredients (Inactive ingredients)

water, glycerin, hydrogen peroxide, poloxamer 407, flavor, polysorbate 80, sodium saccharin, sucralose, phosphoric acid, disodium phosphate

Principal Display Panel 473 Ml Bottle Label (PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label)

+FLUORIDE

CREST

PRO-HEALTH

ADVANCED

ANTICAVITY FLUORIDE RINSE

EXTRA WHITENING

ALCOHOL FREE

IMPORTANT:

Read directions

for proper use.

KILLS BAD BREATH GERMS

WHITER SMILE** IN 7 DAYS

HELPS PREVENT CAVITIES

STRENGTHENS ENAMEL

FRESHENS BREATH

473mL

(16 FL OZ)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)