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QCare Oral Cleansing and Suctioning System, Q4

Dosage form: kit
Ingredients: HYDROGEN PEROXIDE 15mg in 1mL; CETYLPYRIDINIUM CHLORIDE 0.5mg in 1mL;
Labeler: Sage Products LLC
NDC Code: 53462-804

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

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:
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.

Oropharyngeal Suction Catheter:
Aids in the removal of secretions from the oropharyngeal cavity only.

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 Handle.
  • Clean teeth and oral cavity for approximately one minute.
  • To suction, slide switch to ON. When finished, return switch to OFF.
  • To clear tubing, rinse with sterile saline or appropriate solution.
  • Discard Suction Swab. Reattach Covered Yankauer to Suction Handle.
  • 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 Handle.
  • Clean teeth and oral cavity for approximately one minute.
  • To suction, slide switch to ON. When finished, return switch to OFF.
  • To clear tubing, rinse with sterile saline or appropriate solution.
  • Discard Toothbrush. Reattach Covered Yankauer to Suction Handle.
  • 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.

Oropharyngeal Suction Catheter:

  • Peel lid to open.
  • Attach Suction Cather to Suction Handle.
  • Suction secretions from the oropharyngeal cavity.
  • To suction, slide switch to ON. When finished, return switch to OFF.
  • To clear tubing, rinse with sterile saline or appropriate solution.
  • Discard Suction Catheter. Reattach Covered Yankauer to Suction Handle.
  • Use a bite block when performing oral care on patients with altered levels of consciousness or those who cannot comprehend commands.

Caution

  • Federal (U.S.A.) law restricts this device to sale by or on the order of a physician or licensed practicioner.

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

NOT MADE WITH NATURAL RUBBER LATEX. FOR SINGLE USE ONLY. MADE IN U.S.A.

QCare Oral Cleansing and Suctioning System, Q4

QCare Oral Cleansing and Suctioning System, Q8

Antiplaque Solution, Perox-A-Mint

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 
cetylpyridinium chloride and hydrogen peroxide kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53462-804
Packaging
#Item CodePackage Description
1NDC:53462-804-601 KIT in 1 KIT
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 14 PACKET 28 mL
Part 22 PACKET 14 mL
Part 3
Part 46 PACKET 12 g
Part 1 of 4
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 mg  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
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
Part 2 of 4
ANTIPLAQUE SOLUTION 
cetylpyridinium chloride mouthwash
Product Information
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
SORBITOL 
POTASSIUM SORBATE 
POLYSORBATE 80 
POLYSORBATE 20 
FD&C BLUE NO. 1 
WATER 
CITRIC ACID MONOHYDRATE 
Packaging
#Item CodePackage Description
12 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
Part 3 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 4 of 4
MOUTH MOISTURIZER 
Product Information
Ingredients
Ingredient NameQuantity
CETYLPYRIDINIUM CHLORIDE 
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) 
COCONUT OIL 
XYLITOL 
CARBOXYMETHYLCELLULOSE SODIUM 
.ALPHA.-TOCOPHEROL ACETATE 
WATER 
POLYSORBATE 20 
POLYSORBATE 80 
POTASSIUM SORBATE 
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
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35606/30/2004
QCARE ORAL CLEANSING AND SUCTIONING SYSTEM, Q8 
cetylpyridinium chloride and hydrogen peroxide kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53462-808
Packaging
#Item CodePackage Description
1NDC:53462-808-601 KIT in 1 KIT
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 PACKET 7 mL
Part 22 PACKET 14 mL
Part 3
Part 43 PACKET 6 g
Part 1 of 4
PEROX-A-MINT SOLUTION 
hydrogen peroxide mouthwash
Product Information
Item Code (Source)NDC:53462-075
Route of AdministrationBUCCALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROGEN PEROXIDE (HYDROGEN PEROXIDE) HYDROGEN PEROXIDE15 mg  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 KIT
1NDC:53462-075-607 mL in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35605/21/1998
Part 2 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
SORBITOL 
POTASSIUM SORBATE 
POLYSORBATE 80 
POLYSORBATE 20 
FD&C BLUE NO. 1 
WATER 
CITRIC ACID MONOHYDRATE 
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 finalpart35605/21/1998
Part 3 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 4 of 4
MOUTH MOISTURIZER 
Product Information
Ingredients
Ingredient NameQuantity
CARBOXYMETHYLCELLULOSE SODIUM 
.ALPHA.-TOCOPHEROL ACETATE 
WATER 
POLYSORBATE 20 
POLYSORBATE 80 
POTASSIUM SORBATE 
CETYLPYRIDINIUM CHLORIDE 
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) 
COCONUT OIL 
XYLITOL 
Packaging
#Item CodePackage Description
13 PACKET in 1 KIT
12 g in 1 PACKET
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 finalpart35606/30/2004
Labeler - Sage Products LLC (054326178)
Registrant - Sage Products LLC (054326178)

 
Sage Products LLC

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Medically reviewed on Apr 25, 2018

Further information

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