QCare Oral Cleansing and Suctioning System, Q8

Manufacturer
Sage Products LLC
Effective date
2022-02-22
Label type
HUMAN OTC DRUG LABEL
Version
11
Source
full-release
Hydrated at
2026-05-31 23:48:25

Label at a glance#

ProductQCare Oral Cleansing and Suctioning System, Q4
Active ingredientHYDROGEN PEROXIDE, CETYLPYRIDINIUM CHLORIDE
Label structure10 sections

Indications and uses

Suction Swab with Perox-A-Mint: Aids in the removal of secretions and debris. Suction Toothbrush with Antiplaque Solution: Aids in the removal and prevention of plaque that leads to gingivitis. Oropharyngeal Suction Catheter: Aids in the removal of secretions from the oropharyngeal cavity only.

Dosage and administration

Suction Swab with Perox-A-Mint Solution: Before opening, turn package over, burst solution packet with thumbs. Peel lid to open. Remove Mouth Moisturizer and Applicator Swab. Attach Suction Swab to Suction Handle. Clean teeth and oral cavity for approximately one minute. To suction, slide switch to ON. When finished, return switch to OFF. To clear tubing, rinse with sterile saline or appropriate solution. Discard ...

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient: PEROX-A-MINT: Purpose
Hydrogen Peroxide 1.5%Oral Debriding Agent
Active Ingredient: ANTIPLAQUE*: Purpose
Cetylpyridinium chloride .05%Antigingivitis/antiplaque

USES

OTC - WHEN USING SECTION

Suction Swab with Perox-A-Mint:
Aids in the removal of secretions and debris.

Suction Toothbrush with Antiplaque Solution:
Aids in the removal and prevention of plaque that leads to gingivitis.

Oropharyngeal Suction Catheter:
Aids in the removal of secretions from the oropharyngeal cavity only.

WARNINGS

WARNINGS SECTION

Suction Swab with Perox-A-Mint Solution:

Stop use and ask a doctor if:
  • Sore mouth symptoms do not improve in 7 days.
  • Swelling, rash or fever develops.
  • Irritation, pain or redness persists or worsens.

Suction Toothbrush with Antiplaque Solution:

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 increasing spacing between the teeth. These may be signs or symptoms of periodontitis, a serious form of gum disease.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Suction Swab with Perox-A-Mint Solution:
Keep out of reach of children.
If more than used for debriding is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Suction Toothbrush with Antiplaque Solution:
Keep out of reach of children under 6 years of age
If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS

OTC - PURPOSE SECTION

Suction Swab with Perox-A-Mint Solution:

  • Before opening, turn package over, burst solution packet with thumbs.
  • Peel lid to open.
  • Remove Mouth Moisturizer and Applicator Swab.
  • Attach Suction Swab to Suction Handle.
  • Clean teeth and oral cavity for approximately one minute.
  • To suction, slide switch to ON. When finished, return switch to OFF.
  • To clear tubing, rinse with sterile saline or appropriate solution.
  • Discard Suction Swab. Reattach Covered Yankauer to Suction Handle.
  • Place Mouth Moisturizer on Applicator Swab.
  • Apply as needed to lips and inside mouth.
  • Use up to 4 times daily or as directed by a dentist or doctor.
  • Children under 12 years of age: supervise use.
  • Children under 3 years of age: consult a dentist or doctor.
  • Use a bite block when performing oral care on patients with altered levels of consciousness or those who cannot comprehend commands.
  • Ensure foam is intact after use. If not, remove any particles from oral cavity.

Suction Toothbrush with Antiplaque Solution:

  • Before opening, turn package over, burst solution packet with thumbs.
  • Peel lid to open.
  • Remove Mouth Moisturizer and Applicator Swab.
  • Attach Toothbrush to Suction Handle.
  • Clean teeth and oral cavity for approximately one minute.
  • To suction, slide switch to ON. When finished, return switch to OFF.
  • To clear tubing, rinse with sterile saline or appropriate solution.
  • Discard Toothbrush. Reattach Covered Yankauer to Suction Handle.
  • Place Mouth Moisturizer on Applicator Swab.
  • Apply as needed to lips and inside mouth.
  • Adults and children 12 years of age and older: use two times daily or as directed by a dentist. Do not swallow the solution.
  • Children ages 6 to 12 years: supervise use.
  • Children under 6 years of age: do not use.
  • Use a bite block when performing oral care on patients with altered levels of consciousness or those who cannot comprehend commands.
  • Ensure foam is intact after use. If not, remove any particles from oral cavity.

Oropharyngeal Suction Catheter:

  • Peel lid to open.
  • Attach Suction Cather to Suction Handle.
  • Suction secretions from the oropharyngeal cavity.
  • To suction, slide switch to ON. When finished, return switch to OFF.
  • To clear tubing, rinse with sterile saline or appropriate solution.
  • Discard Suction Catheter. Reattach Covered Yankauer to Suction Handle.
  • Use a bite block when performing oral care on patients with altered levels of consciousness or those who cannot comprehend commands.

Caution

  • Federal (U.S.A.) law restricts this device to sale by or on the order of a physician or licensed practicioner.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Suction Swab with Perox-A-Mint Solution:

Water, menthol flavor, polysorbate 80, phosphoric acid, sodium saccharin, Blue 1 (CI 42090), Yellow 6 (CI 15985)

Suction Toothbrush with Antiplaque Solution:

Water, sorbitol, peppermint flavor, potassium sorbate, polysorbate 80, polysorbate 20, citric acid, Blue 1 (CI42090)

Questions?

OTC - QUESTIONS SECTION

Call toll-free 800–323–2220

Manufactured for Sage Products LLC Cary, IL

NOT MADE WITH NATURAL RUBBER LATEX. FOR SINGLE USE ONLY. MADE IN U.S.A.

QCare Oral Cleansing and Suctioning System, Q4

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

QCare 6804QCare 6804QCare Film 6804QCare Film 6804QCare Drug Facts 6804QCare Drug Facts 6804

QCare Oral Cleansing and Suctioning System, Q8

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

QCare 6808QCare 6808QCare film 6808QCare film 6808QCare Drug Facts 6808QCare Drug Facts 6808

Antiplaque Solution, Perox-A-Mint

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Antiplaque SolutionAntiplaque SolutionPerox-A-MintPerox-A-Mint

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1251617cetylpyridinium chloride 0.05 % MouthwashPSN11
358975hydrogen peroxide 1.5 % MouthwashPSN11
1866540Perox-A-Mint 1.5 % MouthwashPSN11
1866540hydrogen peroxide 15 MG/ML Mouthwash [Perox-A-Mint]SBD11
1251617cetylpyridinium chloride 0.5 MG/ML MouthwashSCD11
358975hydrogen peroxide 15 MG/ML MouthwashSCD11
1251617cetylpyridinium chloride 0.05 % MouthwashSY11
358975hydrogen peroxide 1.5 % MouthwashSY11
1866540Perox-A-Mint 1.5 % MouthwashSY11
1866540Perox-A-Mint 15 MG/ML MouthwashSY11

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53462-804-602024-01-30C16284748780-11030e365-3ddb-111a-e063-dadaa90a10e2QCare Oral Cleansing and Suctioning System

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53462-804-60QCare Oral Cleansing and Suctioning System, Q41 in 1 KITKIT111
53462-075-60QCare Oral Cleansing and Suctioning System, Q87 mL in 1 PACKETMOUTHWASH7 mL15 mg in 1mL11
53462-275-60QCare Oral Cleansing and Suctioning System, Q87 mL in 1 PACKETMOUTHWASH14 mL0.5 mg in 1mL11
53462-808-60QCare Oral Cleansing and Suctioning System, Q81 in 1 KITKIT111

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53462-075QCARE ORAL CLEANSING AND SUCTIONING SYSTEM, Q4 (CETYLPYRIDINIUM CHLORIDE AND HYDROGEN PEROXIDE) KIT QCARE ORAL CLEANSING AND SUCTIONING SYSTEM, Q8 (CETYLPYRIDINIUM CHLORIDE AND HYDROGEN PEROXIDE) KIT [SAGE PRODUCTS LLC]11Current NDC, Legacy NDC20220223_f30104fd-7f9a-4db1-8006-36b5b6d7ddae.zip
53462-275QCARE ORAL CLEANSING AND SUCTIONING SYSTEM, Q4 (CETYLPYRIDINIUM CHLORIDE AND HYDROGEN PEROXIDE) KIT QCARE ORAL CLEANSING AND SUCTIONING SYSTEM, Q8 (CETYLPYRIDINIUM CHLORIDE AND HYDROGEN PEROXIDE) KIT [SAGE PRODUCTS LLC]11Current NDC, Legacy NDC20220223_f30104fd-7f9a-4db1-8006-36b5b6d7ddae.zip
53462-804QCARE ORAL CLEANSING AND SUCTIONING SYSTEM, Q4 (CETYLPYRIDINIUM CHLORIDE AND HYDROGEN PEROXIDE) KIT QCARE ORAL CLEANSING AND SUCTIONING SYSTEM, Q8 (CETYLPYRIDINIUM CHLORIDE AND HYDROGEN PEROXIDE) KIT [SAGE PRODUCTS LLC]11Legacy NDC, 1 package rows20220223_f30104fd-7f9a-4db1-8006-36b5b6d7ddae.zip
53462-808QCARE ORAL CLEANSING AND SUCTIONING SYSTEM, Q4 (CETYLPYRIDINIUM CHLORIDE AND HYDROGEN PEROXIDE) KIT QCARE ORAL CLEANSING AND SUCTIONING SYSTEM, Q8 (CETYLPYRIDINIUM CHLORIDE AND HYDROGEN PEROXIDE) KIT [SAGE PRODUCTS LLC]11Legacy NDC, 3 package rows20220223_f30104fd-7f9a-4db1-8006-36b5b6d7ddae.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53462-075-30ML - Milliliter53462-075beb020b4-a3b3-402a-afb9-4fd8e44bcf6f12013-11-04
53462-075-40ML - Milliliter53462-075dfa841fb-924e-4efb-bc49-688eeb1c471c12013-11-04

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 27 matching rows.

NDC Codes#

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 2 · 62 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Antiplaque solutionCETYLPYRIDINIUM CHLORIDESage Products LLC881d4d08-4b45-486a-93af-18c0e00a5b0e2026-06-29WarningsExact identifier
ndc (package): 53462-275-60
ndc (product): 53462-275
ndc11 (package): 53462027560
Perox-A-Mint SolutionHYDROGEN PEROXIDESage Products, LLC50823ff5-ad08-4449-bc4a-9a8ae25ec0d52026-06-24WarningsExact identifier
ndc (package): 53462-075-60
ndc (product): 53462-075
ndc11 (package): 53462007560
d8a00045-194b-4d0f-e053-2a95a90ad47ff30104fd-7f9a-4db1-8006-36b5b6d7ddae2022-02-22WarningsExact identifier
spl id: d8a00045-194b-4d0f-e053-2a95a90ad47f
spl set id: f30104fd-7f9a-4db1-8006-36b5b6d7ddae

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.