assured fresh mint oral health rinse

assured fresh mint oral health rinse
SPL v3
SPL
SPL Set ID 9571bc73-d1c5-4550-e053-2a95a90a886b
Route
oral
Published
Effective Date 2019-10-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
cetylpyridinium (0.07 g)
Inactive Ingredients
sodium benzoate sucralose water benzoic acid poloxamer 188 glycerin saccharin fd&c blue no. 1 propylene glycol

Identifiers & Packaging

Pill Appearance
Color: blue
Marketing Status
otc monograph not final active Since 2019-10-21
Description

For better oral hygiene and fresher breath Drug Facts

Medication Information

Warnings and Precautions

Warnings

Active Ingredient

Active ingredient

Cetylpyridinium chloride 0.07%

Indications and Usage

Use helps control plaque that leads to gingivitis

Dosage and Administration

Directions

  • adults and children 6 years & older: rinse for 30 seconds with 20 mL (4 teaspoonfuls) twice a day
  • do not swallow
  • children 6 to under 12 years of age: supervise use
  • when used after brushing. rinse mouth with water first
  • children under 6 years of age: do not use
Description

For better oral hygiene and fresher breath Drug Facts

Section 42229-5

For better oral hygiene and fresher breath

Drug Facts

Section 50565-1

Keep out of reach of children under 6 years of age. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a dentist if

  • gingivitis, bleeding, or redness persists for more than 2 weeks
  • you have painful or swollen gums, pus from the gum line, loose teeth or increased spacing between the teeth. These may be symptoms of periodontitis, a serious form of gum disease.
Section 51727-6

Inactive ingredients water, glycerin, flavor, poloxamer 188, sodium saccharin, propylene glycol, sodium benzoate, sucralose, benzoic acid, blue 1

Section 51945-4

COMPARES TO ACTIVE INGREDIENTS OF CREST PRO-HEALTH®*

Assured™

FRESH MINT

ORAL HEALTH RINSE

MULTI-ACTION ALCOHOL-FREE ANTISEPTIC

ANTIGINGIVITIS / ANTIPLAQUE

Kills Germs that Cause Bad Breath, Plaque and the Gum Disease Gingivitis

Alcohol Free, Freshens Breath

16.9 FL OZ (500 mL)

Section 55105-1

Purpose

Antigingivitis, Antiplaque

Section 60561-8

Other information

  • this rinse is not intended to replace brushing or flossing

Structured Label Content

Warnings and Precautions (34071-1)

Warnings

Active Ingredient (55106-9)

Active ingredient

Cetylpyridinium chloride 0.07%

Indications and Usage (34067-9)

Use helps control plaque that leads to gingivitis

Dosage and Administration (34068-7)

Directions

  • adults and children 6 years & older: rinse for 30 seconds with 20 mL (4 teaspoonfuls) twice a day
  • do not swallow
  • children 6 to under 12 years of age: supervise use
  • when used after brushing. rinse mouth with water first
  • children under 6 years of age: do not use
Section 42229-5 (42229-5)

For better oral hygiene and fresher breath

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children under 6 years of age. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a dentist if

  • gingivitis, bleeding, or redness persists for more than 2 weeks
  • you have painful or swollen gums, pus from the gum line, loose teeth or increased spacing between the teeth. These may be symptoms of periodontitis, a serious form of gum disease.
Section 51727-6 (51727-6)

Inactive ingredients water, glycerin, flavor, poloxamer 188, sodium saccharin, propylene glycol, sodium benzoate, sucralose, benzoic acid, blue 1

Section 51945-4 (51945-4)

COMPARES TO ACTIVE INGREDIENTS OF CREST PRO-HEALTH®*

Assured™

FRESH MINT

ORAL HEALTH RINSE

MULTI-ACTION ALCOHOL-FREE ANTISEPTIC

ANTIGINGIVITIS / ANTIPLAQUE

Kills Germs that Cause Bad Breath, Plaque and the Gum Disease Gingivitis

Alcohol Free, Freshens Breath

16.9 FL OZ (500 mL)

Section 55105-1 (55105-1)

Purpose

Antigingivitis, Antiplaque

Section 60561-8 (60561-8)

Other information

  • this rinse is not intended to replace brushing or flossing

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:59:39.914809 · Updated: 2026-03-14T22:59:45.666904