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

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 55106-9

Active ingredient

Cetylpyridinium chloride 0.07%

Section 60561-8

Other information

  • this rinse is not intended to replace brushing or flossing

Structured Label Content

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
Warnings and Precautions (34071-1)

Warnings

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 55106-9 (55106-9)

Active ingredient

Cetylpyridinium chloride 0.07%

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)