crest ®

crest ®
SPL v4
SPL
SPL Set ID 15d70b80-3b25-bc32-e063-6394a90a163e
Route
oral
Published
Effective Date 2014-04-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
fluoride ion (2.2 mg)
Inactive Ingredients
glycerin water poloxamer 407 cetylpyridinium chloride saccharin sodium phosphoric acid methylparaben sucralose propylparaben sodium phosphate, dibasic, anhydrous fd&c yellow no. 6 fd&c green no. 3

Identifiers & Packaging

Pill Appearance
Color: green
Marketing Status
otc monograph drug active Since 2020-01-31

Purpose

Anticavity

Description

Drug Facts


Medication Information

Purpose

Anticavity

Directions
  • Adults and children 6 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 6 years of age: Consult a dentist or doctor.
Inactive Ingredients

water, glycerin, flavor, poloxamer 407, cetylpyridinium chloride, sodium saccharin, phosphoric acid, methylparaben, sucralose, propylparaben, disodium phosphate, yellow 6, green 3

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 0.02% (0.01% w/v fluoride ion)

Principal Display Panel 500 Ml Bottle Label

+ FLUORIDE

Crest

PRO-HEALTH

ADVANCED

ANTICAVITY FLUORIDE MOUTHWASH

ALCOHOL FREE

ANTI-CAVITY

IMPORTANT:

Read directions for proper use

MAX CAVITY

PROTECTION

PROTECTS AGAINST CAVITIES

REBUILDS WEAKENED ENAMEL

STRENGTHENS TEETH

CLEANS THE WHOLE MOUTH

FRESHENS BREATH

NO ALCOHOL BURN

500 mL

(16.9 fl oz)


Structured Label Content

Purpose

Anticavity

Directions
  • Adults and children 6 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 6 years of age: Consult a dentist or doctor.
Inactive Ingredients (Inactive ingredients)

water, glycerin, flavor, poloxamer 407, cetylpyridinium chloride, sodium saccharin, phosphoric acid, methylparaben, sucralose, propylparaben, disodium phosphate, yellow 6, green 3

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 0.02% (0.01% w/v fluoride ion)

Principal Display Panel 500 Ml Bottle Label (PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label)

+ FLUORIDE

Crest

PRO-HEALTH

ADVANCED

ANTICAVITY FLUORIDE MOUTHWASH

ALCOHOL FREE

ANTI-CAVITY

IMPORTANT:

Read directions for proper use

MAX CAVITY

PROTECTION

PROTECTS AGAINST CAVITIES

REBUILDS WEAKENED ENAMEL

STRENGTHENS TEETH

CLEANS THE WHOLE MOUTH

FRESHENS BREATH

NO ALCOHOL BURN

500 mL

(16.9 fl oz)


Advanced Ingredient Data


Raw Label Data

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