CETYLPYRIDINIUM CHLORIDE

Manufacturer
Sage Products LLC
Effective date
2019-10-23
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:01:18

Label at a glance#

ProductQCare Oral Cleansing and Suctioning System compatible with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse
Active ingredientCETYLPYRIDINIUM CHLORIDE
Label structure10 sections

Indications and uses

Suction Swab with Corinz Antiseptic Cleansing and Moisturizing Oral Rinse Aids in the removal of secretions and debris and helps reduce the chance of infection in minor oral irritation. Suction Toothbrush CHG compatible* Aids in the removal of dental plaque, debris and secretions. Oropharyngeal Suction Catheter Non-sterile Aids in the removal of secretions from the oropharyngeal cavity only.

Dosage and administration

Suction Swab with Antiseptic Oral Rinse 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 line. Clean teeth and oral cavity for approximately one minute. To suction, place thumb over port. To clear tubing, rinse with sterile saline or appropriate solution. Discard Suction Swab. Reattach Covered Yanka...

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Suction Swab with Antiseptic Oral Rinse

Active Ingredient:

Corinz™ Antiseptic Cleansing and Moisturizing Oral Rinse:

Cetylpyridinium chloride 0.05%

Purpose
Antiseptic Rinse
*Compatible for use with 0.12% Chlorhexidine Gluconate (CHG) oral rinse, tested for use up to five minutes.
NOTE: The following Uses and Directions refer to the Suction Toothbrush and Swab. For Warnings, Uses and Directions specific to the CHG rinse including use in children under 18 years of age, refer to that product’s package insert and labeling.

Uses

OTC - WHEN USING SECTION

Suction Swab with Corinz Antiseptic Cleansing and Moisturizing Oral Rinse

  • Aids in the removal of secretions and debris and helps reduce the chance of infection in minor oral irritation.

Suction Toothbrush CHG compatible*

  • Aids in the removal of dental plaque, debris and secretions.

Oropharyngeal Suction Catheter Non-sterile

  • Aids in the removal of secretions from the oropharyngeal cavity only.

WARNINGS

WARNINGS SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

OTC - PURPOSE SECTION

Suction Swab with Antiseptic Oral Rinse
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 line.
  • Clean teeth and oral cavity for approximately one minute.
  • To suction, place thumb over port.
  • To clear tubing, rinse with sterile saline or appropriate solution.
  • Discard Suction Swab. Reattach Covered Yankauer to suction line.
  • 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 CHG compatible*

  • Peel lid to open.
  • Remove Suction Toothbrush and attach to suction line.
  • When using with a cleansing solution, refer to the product packaging for indications, instructions and warnings.
  • To suctions, place thumb over port.
  • To clear tubing, rinse with sterile saline or appropriate solution.
  • Discard Suction Toothbrush. Reattach Covered Yankauer to suction line.
  • Use Swab for additional cleansing as needed.
  • Use two 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.


Oropharyngeal Suction Catheter Non-sterile

  • Peel lid to open.
  • Attach Suction Catheter to suction line.
  • Suction secretions from the oropharyngeal cavity.
  • To suction, place thumb over port.
  • To clear tubing, rinse with sterile saline or appropriate solution.
  • Discard Suction Catheter. Reattach Covered Yankauer to suction line.
  • Use a bite block when performing oral care on patients with altered levels of consciousness or those who cannot comprehend commands.
  • Oropharyngeal Suction Catheter Non-sterile

Caution

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Suction Swab with Corinz Antiseptic Cleansing and Moisturizing Oral Rinse


Water, glycerin, xylitol, spearmint flavor, potassium sorbate, polysorbate 20, polysorbate 80, hydroxyethylcellulose, citric acid, sodium saccharin, menthol.

Questions?

OTC - QUESTIONS SECTION

Call toll-free 800–323–2220

SPL UNCLASSIFIED SECTION

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

Manufactured for:
Sage Products LLC
Cary, IL 60013

1-800-323-2220

QCare Oral Cleansing & Suctioning System compatible with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

6994 Bag Label6994 Bag Label

6994 Film6994 Film6994 Blister Label6994 Blister Label

Corinz Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Corinz LabelCorinz Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1251617cetylpyridinium chloride 0.05 % MouthwashPSN3
1251617cetylpyridinium chloride 0.5 MG/ML MouthwashSCD3
1251617cetylpyridinium chloride 0.05 % MouthwashSY3

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53462-994-602021-01-29C16284748780-1ba0f9c33-33ff-a910-e053-dadaa90a0b85QCare Oral Cleansing & Suctioning System compatible with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53462-994-60QCare Oral Cleansing and Suctioning System compatible with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse1 in 1 KITKIT13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53462-994QCARE ORAL CLEANSING AND SUCTIONING SYSTEM COMPATIBLE WITH 0.12% CHLORHEXIDINE GLUCONATE (CHG) ORAL RINSE (CETYLPYRIDINIUM CHLORIDE) KIT [SAGE PRODUCTS LLC]3Legacy NDC, 1 package rows20191024_69dc3f73-5992-45d2-95cc-3ba5dd40b470.zip

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53462-99453462-994-60
53462-375

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CorinzCETYLPYRIDINIUM CHLORIDESage Products, LLC685b6023-89c4-417e-af2d-52e831855da12026-06-29WarningsExact identifier
ndc (product): 53462-375
9596c853-ac54-f873-e053-2a95a90a682369dc3f73-5992-45d2-95cc-3ba5dd40b4702019-10-23WarningsExact identifier
spl id: 9596c853-ac54-f873-e053-2a95a90a6823
spl set id: 69dc3f73-5992-45d2-95cc-3ba5dd40b470

Reported adverse events (FAERS/openFDA)#

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