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QCare Oral Cleansing and Suctioning System Q4 Antiseptic Oral Rinse

Medically reviewed on March 1, 2017

Dosage form: kit
Ingredients: ; CETYLPYRIDINIUM CHLORIDE 0.5mg in 1mL
Labeler: Sage Products LLC
NDC Code: 53462-414

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 Purpose
 ANTISEPTIC ORAL RINSE
 Cetylpyridinium chloride .05% Antiseptic Rinse

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.

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.

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 Antiseptic Oral Rinse
Water, sorbitol, peppermint flavor, potassium sorbate, polysorbate 80, polysorbate 20, citric acid, Blue 1 (CI 42090).

Drug Facts
Suction Toothbrush with Antiplaque Solution
 Active Ingredient Purpose
 ANTIPLAQUE
 Cetylpyridinium chloride .05% Antigingivitis / antiplaque

Uses

Suction Toothbrush with Antiplaque Solution

  • Aids in the removal and prevention of plaque that leads to gingivitis.

Warnings

Stop use and ask a dentist if:
• Gingivitis, bleeding or redness persists for more than 2 weeks.
• You have painful or swollen gum, 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.

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

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 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.
  • 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 age 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.

Inactive Ingredients

Suction Toothbrush with Antiplaque Solution
Water, sorbitol, peppermint flavor, potassium sorbate, polysorbate 80, polysorbate 20, citric acid, Blue 1 (CI 42090).

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

QCare Oral Cleansing and Suctioning System Q4 Reorder# 6414

QCare Oral Cleansing & Suctioning System Q4 Reorder# 6404

Established Pharmacological Class
SubstancePharmacological Class
Sodium BicarbonateOther Oral Hygiene Products
Mouth MoisturizerOther Oral Hygiene Products
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:53462-414
Packaging
#Item CodePackage Description
1NDC:53462-414-601 KIT in 1 KIT
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 1
Part 26 PACKET 12 g
Part 32 PACKET 14 mL
Part 44 PACKET 28 mL
Part 1 of 4
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 2 of 4
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 
Packaging
#Item CodePackage Description
16 PACKET in 1 KIT
12 g in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Cosmetic
Part 3 of 4
ANTIPLAQUE SOLUTION 
cetylpyridinium chloride mouthwash
Product Information
Item Code (Source)NDC:53462-275
Route of AdministrationBUCCALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETYLPYRIDINIUM CHLORIDE (CETYLPYRIDINIUM) CETYLPYRIDINIUM CHLORIDE0.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
SORBITOL 
PEPPERMINT 
POTASSIUM SORBATE 
POLYSORBATE 80 
POLYSORBATE 20 
CITRIC ACID MONOHYDRATE 
FD&C BLUE NO. 1 
Packaging
#Item CodePackage Description
12 PACKET in 1 KIT
1NDC:53462-275-607 mL in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35601/09/2009
Part 4 of 4
ANTISEPTIC ORAL RINSE 
cetylpyridinium chloride mouthwash
Product Information
Item Code (Source)NDC:53462-175
Route of AdministrationBUCCALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETYLPYRIDINIUM CHLORIDE (CETYLPYRIDINIUM) CETYLPYRIDINIUM CHLORIDE0.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
SORBITOL 
PEPPERMINT 
POTASSIUM SORBATE 
POLYSORBATE 80 
POLYSORBATE 20 
CITRIC ACID MONOHYDRATE 
FD&C BLUE NO. 1 
Packaging
#Item CodePackage Description
14 PACKET in 1 KIT
17 mL in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35605/21/1998
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35606/30/2006
QCARE ORAL CLEANSING AND SUCTIONING SYSTEM Q4 ANTISEPTIC ORAL RINSE 
cetylpyridinium chloride kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53462-404
Packaging
#Item CodePackage Description
1NDC:53462-404-601 KIT in 1 KIT
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 1
Part 26 PACKET 12 g
Part 32 PACKET 14 mL
Part 44 PACKET 28 mL
Part 1 of 4
SODIUM BICARBONATE 
Product Information
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 2 of 4
MOUTH MOISTURIZER 
Product Information
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 
Packaging
#Item CodePackage Description
16 PACKET in 1 KIT
12 g in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Cosmetic
Part 3 of 4
ANTIPLAQUE SOLUTION 
cetylpyridinium chloride mouthwash
Product Information
Item Code (Source)NDC:53462-275
Route of AdministrationBUCCALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETYLPYRIDINIUM CHLORIDE (CETYLPYRIDINIUM) CETYLPYRIDINIUM CHLORIDE0.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
SORBITOL 
PEPPERMINT 
POTASSIUM SORBATE 
POLYSORBATE 80 
POLYSORBATE 20 
CITRIC ACID MONOHYDRATE 
FD&C BLUE NO. 1 
Packaging
#Item CodePackage Description
12 PACKET in 1 KIT
1NDC:53462-275-607 mL in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35601/09/2009
Part 4 of 4
ANTISEPTIC ORAL RINSE 
cetylpyridinium chloride mouthwash
Product Information
Item Code (Source)NDC:53462-175
Route of AdministrationBUCCALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETYLPYRIDINIUM CHLORIDE (CETYLPYRIDINIUM) CETYLPYRIDINIUM CHLORIDE0.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
SORBITOL 
PEPPERMINT 
POTASSIUM SORBATE 
POLYSORBATE 80 
POLYSORBATE 20 
CITRIC ACID MONOHYDRATE 
FD&C BLUE NO. 1 
Packaging
#Item CodePackage Description
14 PACKET in 1 KIT
17 mL in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35605/21/1998
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35606/30/2005
Labeler - Sage Products LLC (054326178)
Registrant - Sage Products LLC (054326178)
Establishment
NameAddressID/FEIOperations
Sage Products LLC054326178manufacture(53462-414, 53462-404, 53462-175, 53462-275)

 
Sage Products LLC

← See all QCare Oral Cleansing and Suctioning System Q4 Antiseptic Oral Rinse brands

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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