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QCare Oral Cleansing and Suctioning System Q4 Antiseptic Oral Rinse

Dosage form: kit
Ingredients: CETYLPYRIDINIUM CHLORIDE 5[iU] in 1mL;
Labeler: Sage Products LLC
NDC Code: 53462-944

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 and Suctioning System Q4 – Antiseptic Oral Rinse

Drug Facts
Suction Swab with Antiseptic Oral Rinse
Active Ingredient:
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 Antiseptic 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 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 Yankauerto 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 Antiseptic Oral Rinse
Water, sorbitol, peppermint flavor, potassium sorbate, polysorbate 80, polysorbate 20, citric acid, Blue 1 (CI 42090).

Questions?

Call toll-free 800–323–2220

Manufactured for Sage Products LLC Cary, IL

Keep out of reach of children


Manufactured for:
Sage Products LLC
Cary, IL 60013

1-800-323-2220

QCare Oral Cleansing & Suctioning System, q4
Suction Toothbrush Compatible with Chlorhexidine Gluconate (CHG) Oral Rinse

QCare Oral Cleansing and Suctioning System Q4 – Antiseptic Oral Rinse
Instructions

Established Pharmacological Class
SubstancePharmacological Class
Sodium BicarbonateOther Oral Hygiene Products
Mouth MoisturizerOther Oral Hygiene Products
QCARE ORAL CLEANSING AND SUCTIONING SYSTEM Q4 ANTISEPTIC ORAL RINSE 
cetylpyridinium chloride kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53462-944
Packaging
#Item CodePackage Description
1NDC:53462-944-601 KIT in 1 KIT
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 12 POUCH 14 mL  in 2 
Part 2
Part 3
Part 1 of 3
SUCTION SWAB WITH ANTISEPTIC ORAL RINSE 
cetylpyridinium chloride mouthwash
Product Information
Route of AdministrationBUCCALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETYLPYRIDINIUM CHLORIDE (CETYLPYRIDINIUM) CETYLPYRIDINIUM CHLORIDE5 [iU]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
SORBITOL 
POTASSIUM SORBATE 
POLYSORBATE 80 
POLYSORBATE 20 
CITRIC ACID MONOHYDRATE 
FD&C BLUE NO. 1 
Packaging
#Item CodePackage Description
11 PACKET in 1 PACKAGE
11 POUCH in 1 PACKET
17 mL in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35605/21/1998
Part 2 of 3
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
Part 3 of 3
MOUTH MOISTURIZER 
mouth moisturizer emulsion
Product Information
Route of AdministrationBUCCALDEA Schedule    
Ingredients
Ingredient NameQuantity
COCONUT OIL 
XYLITOL 
CARBOXYMETHYLCELLULOSE SODIUM 
.ALPHA.-TOCOPHEROL ACETATE 
WATER 
POLYSORBATE 20 
POLYSORBATE 80 
POTASSIUM SORBATE 
CETYLPYRIDINIUM CHLORIDE 
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) 
SPEARMINT OIL 
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 finalpart35606/01/2015
Labeler - Sage Products LLC (054326178)
Registrant - Sage Products LLC (054326178)
Establishment
NameAddressID/FEIOperations
Sage Products LLC054326178MANUFACTURE(53462-944)

Revised: 10/2015
 
Sage Products LLC

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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