QCare

Manufacturer
Sage Products LLC
Effective date
2015-03-05
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:41:57

Label at a glance#

ProductQCare
Active ingredientCETYLPYRIDINIUM CHLORIDE
Label structure11 sections

Indications and uses

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

Dosage and administration

Toothette Oral Care Suction Toothbrush Before opening, turn package over, burst solution packet with thumbs. Peel lid to open. Attach Toothbrush 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 Toothbrush. Reattach Covered Yankauer to suction line. Use up to 4 times daily or as d...

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient: Purpose
CORINZ ANTISEPTIC CLEANSING AND MOISTURIZING ORAL RINSE:
Cetylpyridinium chloride 0.05%Antiseptic Rinse

Uses

OTC - WHEN USING SECTION

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

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

Toothette Oral Care Suction Toothbrush
  • Before opening, turn package over, burst solution packet with thumbs.
  • Peel lid to open.
  • Attach Toothbrush 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 Toothbrush. Reattach Covered Yankauer to suction line.
  • 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.
Toothette Oral Care Suction Swab
  • Before opening, turn package over, burst solution packet with thumbs.
  • Peel lid to open.
  • 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.
  • 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.

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

LATEX FREE • FOR SINGLE USE ONLY • MADE IN U.S.A.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bag Label
Bag Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bag Label
Bag Label
Film Label
Film Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Burst Pouch
Burst Pouch

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1251617cetylpyridinium chloride 0.05 % MouthwashPSN2
1251617cetylpyridinium chloride 0.5 MG/ML MouthwashSCD2
1251617cetylpyridinium chloride 0.05 % MouthwashSY2

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53462-306-60QCare1 in 1 KITKIT12
53462-308-60QCare1 in 1 KITKIT12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53462-306QCARE (CETYLPYRIDINIUM CHLORIDE) KIT [SAGE PRODUCTS LLC]2Legacy NDC, 1 package rows20150312_d56b7b37-f818-4e7f-9443-3bf7e5a530ee.zip
53462-308QCARE (CETYLPYRIDINIUM CHLORIDE) KIT [SAGE PRODUCTS LLC]2Legacy NDC, 1 package rows20150312_d56b7b37-f818-4e7f-9443-3bf7e5a530ee.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CETYLPYRIDINIUM CHLORIDEACTIVE INGREDIENTD9OM4SK49P2
CETYLPYRIDINIUMACTIVE MOIETYCUB7JI0JV32
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QP2
GLYCERININACTIVE INGREDIENTPDC6A3C0OX2
HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%)INACTIVE INGREDIENTZYD53NBL452
MENTHOL, UNSPECIFIED FORMINACTIVE INGREDIENTL7T10EIP3A2
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YH2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8H2
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ42
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TY2
WATERINACTIVE INGREDIENT059QF0KO0R2
XYLITOLINACTIVE INGREDIENTVCQ006KQ1E2

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53462-30853462-308-60
53462-30653462-306-60
53462-375

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 3 · 126 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPTABLET, ORALLY DISINTEGRATING / ORAL83 mgExact identifier — unii+route
24 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HPOWDER, FOR SUSPENSION / ORAL396 mgExact identifier — unii+route
25 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHTABLET, FILM COATED / ORAL0.35 mgExact identifier — unii+route
6 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4SUSPENSION / ORAL400 mgExact identifier — unii+route
12 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / ORAL446 mgExact identifier — unii+route
24 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHCAPSULE / ORAL563 mgExact identifier — unii+route
6 equally ranked IID candidates
MENTHOL, UNSPECIFIED FORMMENTHOLL7T10EIP3ASUSPENSION / ORAL1 mgExact identifier — unii+route
9 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION/ DROPS / ORAL750 mgExact identifier — unii+route
20 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HCONCENTRATE / ORAL1 mg/1mlExact identifier — unii+route
25 equally ranked IID candidates
XYLITOLXYLITOLVCQ006KQ1EPASTE / ORAL180 mgExact identifier — unii+route
10 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYSYRUP / ORAL24 mgExact identifier — unii+route
17 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHTABLET / ORAL17 mgExact identifier — unii+route
6 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HCAPSULE, COATED / ORAL0.04 mgExact identifier — unii+route
25 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXELIXIR / ORAL5621 mgExact identifier — unii+route
20 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHSUSPENSION / ORAL80 mgExact identifier — unii+route
6 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPGRANULE, FOR SUSPENSION / ORAL113 mgExact identifier — unii+route
24 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET / ORAL42 mgExact identifier — unii+route
20 equally ranked IID candidates
XYLITOLXYLITOLVCQ006KQ1ETABLET, FILM COATED, EXTENDED RELEASE / ORAL72 mgExact identifier — unii+route
10 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYGRANULE, FOR SOLUTION / ORAL5.5 mg/120mlExact identifier — unii+route
17 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HCAPSULE / ORAL418.37 mgExact identifier — unii+route
25 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE, EXTENDED RELEASE / ORAL265 mgExact identifier — unii+route
20 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHPOWDER, FOR SUSPENSION / ORAL1.3 mg/5mlExact identifier — unii+route
6 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4TABLET, COATED / ORALNAExact identifier — unii+route
12 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSUSPENSION / ORAL269 mgExact identifier — unii+route
24 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HPASTE / ORAL28 mgExact identifier — unii+route
25 equally ranked IID candidates
XYLITOLXYLITOLVCQ006KQ1EPOWDER, FOR SUSPENSION / ORAL4223 mgExact identifier — unii+route
10 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPCAPSULE, EXTENDED RELEASE / ORAL101 mgExact identifier — unii+route
24 equally ranked IID candidates
XYLITOLXYLITOLVCQ006KQ1ESUSPENSION / ORAL1500 mgExact identifier — unii+route
10 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSYRUP / ORAL16734 mgExact identifier — unii+route
20 equally ranked IID candidates
XYLITOLXYLITOLVCQ006KQ1ETABLET / ORAL15.04 mgExact identifier — unii+route
10 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYSOLUTION / ORAL665 mgExact identifier — unii+route
17 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET, FILM COATED / ORAL1.55 mgExact identifier — unii+route
20 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4TABLET / ORAL6 mgExact identifier — unii+route
12 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPTABLET, CHEWABLE / ORAL7 mgExact identifier — unii+route
24 equally ranked IID candidates
MENTHOL, UNSPECIFIED FORMMENTHOLL7T10EIP3ASOLUTION / ORAL3 mgExact identifier — unii+route
9 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION / ORAL26208 mgExact identifier — unii+route
20 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HSUSPENSION, EXTENDED RELEASE / ORAL40 mgExact identifier — unii+route
25 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE / ORAL3487 mgExact identifier — unii+route
20 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYPOWDER, FOR SOLUTION / ORAL199 mgExact identifier — unii+route
17 equally ranked IID candidates
MENTHOL, UNSPECIFIED FORMMENTHOLL7T10EIP3ASYRUP / ORAL7.5 mg/5mlExact identifier — unii+route
9 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HSUSPENSION/ DROPS / ORAL23 mgExact identifier — unii+route
25 equally ranked IID candidates
MENTHOL, UNSPECIFIED FORMMENTHOLL7T10EIP3APOWDER, FOR SOLUTION / ORALNAExact identifier — unii+route
9 equally ranked IID candidates
XYLITOLXYLITOLVCQ006KQ1ETABLET, ORALLY DISINTEGRATING / ORAL360 mgExact identifier — unii+route
10 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4SOLUTION / ORAL1000 mg/15mlExact identifier — unii+route
12 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYSUSPENSION / ORAL5000 mg/5mlExact identifier — unii+route
17 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4SYRUP / ORAL2 mg/1mlExact identifier — unii+route
12 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCONCENTRATE / ORAL1800 mgExact identifier — unii+route
20 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL2 mgExact identifier — unii+route
24 equally ranked IID candidates
HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%)HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%)ZYD53NBL45CAPSULE / ORAL2.98 mgExact identifier — unii+route
3 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYELIXIR / ORAL15 mg/5mlExact identifier — unii+route
17 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION, CONCENTRATE / ORAL200 mg/1mlExact identifier — unii+route
20 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4TABLET, EXTENDED RELEASE / ORAL0.2 mgExact identifier — unii+route
12 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPTROCHE / ORAL12 mgExact identifier — unii+route
24 equally ranked IID candidates
POTASSIUM SORBATEPOTASSIUM SORBATE1VPU26JZZ4POWDER, FOR SUSPENSION / ORAL19 mgExact identifier — unii+route
12 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYPASTE / ORAL3 mgExact identifier — unii+route
17 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHTABLET, EXTENDED RELEASE / ORAL4.2 mgExact identifier — unii+route
6 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYLIQUID / ORAL3 mgExact identifier — unii+route
17 equally ranked IID candidates
POLYSORBATE 80POLYSORBATE 806OZP39ZG8HTABLET, COATED / ORAL18 mgExact identifier — unii+route
25 equally ranked IID candidates
MENTHOL, UNSPECIFIED FORMMENTHOLL7T10EIP3ASOLUTION, CONCENTRATE / ORAL0.5 mg/1mlExact identifier — unii+route
9 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYTABLET, FILM COATED / ORAL2 mgExact identifier — unii+route
17 equally ranked IID candidates

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
77cd666b-f9c1-4d44-b1c8-6de5cc1d299dd56b7b37-f818-4e7f-9443-3bf7e5a530ee2015-03-05WarningsExact identifier
spl id: 77cd666b-f9c1-4d44-b1c8-6de5cc1d299d
spl set id: d56b7b37-f818-4e7f-9443-3bf7e5a530ee

Reported adverse events (FAERS/openFDA)#

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