crest ®

crest ®
SPL v11
SPL
SPL Set ID c1420129-5460-4900-ac9a-356d2d7c60a2
Route
oral
Published
Effective Date 2015-04-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
fluoride ion (0.1 mg)
Inactive Ingredients
water glycerin sucralose propylene glycol hydrogen peroxide poloxamer 407 saccharin sodium phosphoric acid sodium phosphate, dibasic, anhydrous

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
otc monograph drug active Since 2015-02-19

Purpose

Anticavity

Description

Drug Facts


Medication Information

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.
Inactive Ingredients

water, glycerin, propylene glycol, hydrogen peroxide, poloxamer 407, flavor, sodium saccharin, phosphoric acid, sucralose, disodium phosphate

Description

Drug Facts

Questions?

1-800-285-9139

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.

Active Ingredient

Sodium Fluoride 0.0219% (0.01% w/v fluoride ion)

Principal Display Panel 473 Ml Bottle Label

WITH FLUORIDE

ALCOHOL FREE



Crest
®



3D WHITE



ANTICAVITY FLUORIDE MOUTHWASH

DIAMOND STRONG

FROM THE MAKERS OF WHITESTRIPS ®

  • STRENGTHENS ENAMEL
  • WHITENS TEETH
  • HELPS PREVENT CAVITIES
  • 91518226

WINTERMINT

IMPORTANT: Read directions for proper use.

946 mL



(32 FL OZ)


Structured Label Content

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.
Inactive Ingredients (Inactive ingredients)

water, glycerin, propylene glycol, hydrogen peroxide, poloxamer 407, flavor, sodium saccharin, phosphoric acid, sucralose, disodium phosphate

Questions?

1-800-285-9139

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.

Active Ingredient (Active ingredient)

Sodium Fluoride 0.0219% (0.01% w/v fluoride ion)

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

WITH FLUORIDE

ALCOHOL FREE



Crest
®



3D WHITE



ANTICAVITY FLUORIDE MOUTHWASH

DIAMOND STRONG

FROM THE MAKERS OF WHITESTRIPS ®

  • STRENGTHENS ENAMEL
  • WHITENS TEETH
  • HELPS PREVENT CAVITIES
  • 91518226

WINTERMINT

IMPORTANT: Read directions for proper use.

946 mL



(32 FL OZ)


Advanced Ingredient Data


Raw Label Data

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