Percara Fresh Mint Oral Health Rinse

Percara Fresh Mint Oral Health Rinse
SPL v2
SPL
SPL Set ID bd98c654-218b-15ac-e053-2a95a90a75d1
Route
ORAL
Published
Effective Date 2021-03-15
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 DRUG Active Since 2021-03-15

Description

Drug Facts


Medication Information

Warnings and Precautions

Warning

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

Drug Facts

Section 42229-5

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.

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

PERCARA™

FRESH MINT

ORAL HEALTH RINSE

ALCOHOL FREE

KILLS GERMS

FRESHENS BREATH

PREVENTS GINGIVITIS

16.9 FL OZ (500mL)

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)

Warning

Section 42229-5 (42229-5)

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.

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)

PERCARA™

FRESH MINT

ORAL HEALTH RINSE

ALCOHOL FREE

KILLS GERMS

FRESHENS BREATH

PREVENTS GINGIVITIS

16.9 FL OZ (500mL)

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

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