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

Dosage form: kit
Ingredients: CETYLPYRIDINIUM CHLORIDE 0.5mg in 1mL;
Labeler: Sage Products LLC
NDC Code: 53462-994

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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

Drug Facts
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

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

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.

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

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

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?

Call toll-free 800–323–2220

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

Corinz Label

Established Pharmacological Class
SubstancePharmacological Class
Sodium BicarbonateOther Oral Hygiene Products
QCARE ORAL CLEANSING AND SUCTIONING SYSTEM COMPATIBLE WITH 0.12% CHLORHEXIDINE GLUCONATE (CHG) ORAL RINSE 
cetylpyridinium chloride kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53462-994
Packaging
#Item CodePackage Description
1NDC:53462-994-601 KIT in 1 KIT
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 14 POUCH 28 mL  in 2 
Part 2
Part 1 of 2
CORINZ 
cetylpyridinium chloride rinse
Product Information
Item Code (Source)NDC:53462-375
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETYLPYRIDINIUM CHLORIDE (CETYLPYRIDINIUM) CETYLPYRIDINIUM CHLORIDE0.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
GLYCERIN 
XYLITOL 
POTASSIUM SORBATE 
POLYSORBATE 20 
POLYSORBATE 80 
HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%) 
CITRIC ACID MONOHYDRATE 
SACCHARIN SODIUM 
MENTHOL, UNSPECIFIED FORM 
Packaging
#Item CodePackage Description
14 POUCH in 1 PACKET
17 mL in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35601/11/2016
Part 2 of 2
SODIUM BICARBONATE 
sodium bicarbonate powder
Product Information
Route of AdministrationBUCCALDEA Schedule    
Ingredients
Ingredient NameQuantity
SODIUM BICARBONATE 
CARBOXYMETHYLCELLULOSE SODIUM 
SODIUM LAURYL SULFATE 
SODIUM BENZOATE 
WATER 
SACCHARIN SODIUM 
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Cosmetic
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35611/16/2016
Labeler - Sage Products LLC (054326178)
Registrant - Sage Products LLC (054326178)
Establishment
NameAddressID/FEIOperations
Sage Products LLC054326178manufacture(53462-994, 53462-375)

 
Sage Products LLC

Medically reviewed on Dec 21, 2016

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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