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QCare Oral Cleansing and Suctioning System, Q4

Medically reviewed on August 20, 2018

Dosage form: kit
Ingredients: HYDROGEN PEROXIDE 15[iU] in 1mL; CETYLPYRIDINIUM CHLORIDE .5[iU] in 1mL
Labeler: Sage Products LLC
NDC Code: 53462-504

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

Drug Facts
Active Ingredient: PEROX-A-MINT:Purpose
Hydrogen Peroxide 1.5%Oral Debriding Agent
Active Ingredient: ANTIPLAQUE*:Purpose
Cetylpyridinium chloride .05%Antigingivitis/antiplaque

USES

Suction Swab with Perox-A-Mint Solution:

  • Aids in the removal of secretions and debris.

Suction Toothbrush with Antiplaque Solution:

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

WARNINGS

Suction Swab with Perox-A-Mint Solution:

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.

Suction Toothbrush with Antiplaque Solution:

Stop use and ask a dentist if:

  • Gingivitis, bleeding or redness persists for more than 2 weeks.
  • You have painful or swollen gums, 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.

Suction Swab with Perox-A-Mint Solution:
Keep out of reach of children.
If more than used for debriding is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Suction Toothbrush with Antiplaque Solution:
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 Swab with Perox-A-Mint Solution:

  • 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 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 ages 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 Swab with Perox-A-Mint Solution:
Water, menthol flavor, polysorbate 80, phosphoric acid, sodium saccharin, Blue 1 (CI 42090), Yellow 6 (CI 15985)

Suction Toothbrush with Antiplaque Solution:
Water, sorbitol, peppermint flavor, potassium sorbate, polysorbate 80, polysorbate 20, citric acid, Blue 1 (CI42090)

Questions?

Call toll-free 800–323–2220

Manufactured for Sage Products LLC Cary, IL

Q·Care® Oral Cleansing and Suctioning System

Q·Care® Oral Cleansing and Suctioning System Label

Q-Care® Oral Cleansing and Suctioning System, q4°

QCARE ORAL CLEANSING AND SUCTIONING SYSTEM, Q4 
cetylpyridinium chloride and hydrogen peroxide kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53462-504
Packaging
#Item CodePackage Description
1NDC:53462-504-601 KIT in 1 KIT
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 POUCH 7 mL
Part 21 POUCH 7 mL
Part 1 of 2
TOOTHETE ORAL CARE SUCTION SWAB WITH PEROX-A-MINT SOLUTION 
hydrogen peroxide mouthwash
Product Information
Route of AdministrationBUCCALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROGEN PEROXIDE (HYDROGEN PEROXIDE) HYDROGEN PEROXIDE15 [iU]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
POLYSORBATE 80 
PHOSPHORIC ACID 
SACCHARIN SODIUM 
FD&C BLUE NO. 1 
FD&C YELLOW NO. 6 
Packaging
#Item CodePackage Description
11 PACKET in 1 PACKAGE
12 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 2
SUCTION TOOTHBRUSH WITH ANTIPLAQUE SOLUTION 
cetylpyridinium chloride mouthwash
Product Information
Route of AdministrationBUCCALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETYLPYRIDINIUM CHLORIDE (CETYLPYRIDINIUM) CETYLPYRIDINIUM CHLORIDE.5 [iU]  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
11 PACKET in 1 PACKAGE
12 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
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35605/21/1998
Labeler - Sage Products LLC (054326178)
Registrant - Sage Products LLC (054326178)
Establishment
NameAddressID/FEIOperations
ChemRite CoPac, Inc.623776502MANUFACTURE(53462-504)
Establishment
NameAddressID/FEIOperations
Sage Products LLC054326178MANUFACTURE(53462-504)

 
Sage Products LLC

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Further information

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

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