crest pro health restore enamel

crest pro health restore enamel
SPL v5
SPL
SPL Set ID c3658e2f-7cdb-b226-e053-2995a90a18f3
Route
oral
Published
Effective Date 2021-05-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
fluoride ion (0.2 mg)
Inactive Ingredients
water propylene glycol poloxamer 407 polysorbate 80 benzoic acid phosphoric acid sucralose sodium benzoate sodium phosphate, dibasic, anhydrous fd&c yellow no. 5 fd&c blue no. 1

Identifiers & Packaging

Pill Appearance
Color: green
Marketing Status
otc monograph drug active Since 2021-01-01
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, propylene glycol, poloxamer 407, polysorbate 80, flavor, benzoic acid, sucralose, sodium benzoate, phosphoric acid, disodium phosphate, blue 1, yellow 5

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 1000 Ml Bottle Label

ALCOHOL FREE

+FLUORIDE

Crest ®

PRO-HEALTH™

ANTICAVITY FLUORIDE RINSE

RESTORES WEAKENED ENAMEL

IMPORTANT: Read directions for proper use.

Protects Against Cavities

Strengthens Teeth

Freshens Breath

CLEAN MINT

1L (33.8 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, propylene glycol, poloxamer 407, polysorbate 80, flavor, benzoic acid, sucralose, sodium benzoate, phosphoric acid, disodium phosphate, blue 1, yellow 5

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 1000 Ml Bottle Label (PRINCIPAL DISPLAY PANEL - 1000 mL Bottle Label)

ALCOHOL FREE

+FLUORIDE

Crest ®

PRO-HEALTH™

ANTICAVITY FLUORIDE RINSE

RESTORES WEAKENED ENAMEL

IMPORTANT: Read directions for proper use.

Protects Against Cavities

Strengthens Teeth

Freshens Breath

CLEAN MINT

1L (33.8 FL OZ)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:41.688955 · Updated: 2026-03-14T23:09:36.432892