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QCare Oral Cleansing and Suctioning System, Q2

Dosage form: kit
Ingredients: HYDROGEN PEROXIDE 15mg in 1mL;
Labeler: Sage Products, LLC
NDC Code: 53462-926

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, Q2

Drug Facts
Suction Swab with Perox-A-Mint Solution
Active Ingredient: PEROX-A-MINT: Purpose
Hydrogen Peroxide 1.5%Oral Debriding Agent
Suction Toothbrush CHG compatible*
*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 Perox-A-Mint Solution

  • Aids in the removal of secretions and debris.

Suction Swab with Alcohol-Free Mouthwash

  • Aids in the removal of debris.
  • Helps the mouth feel fresh and clean
  • Helps temporarily reduce dryness.

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 the reach of children.
If more than used for debriding 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 Swab with Alcohol-Free Mouthwash

  • 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.
  • 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.
  • Children under 12 years of age: supervise 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.

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 suction, 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.
  • Children under 12 years of age: supervise 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 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 Yankaurer 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 physican or licensed practitioner.

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)

Suctions Swab with Alcohol-Free Mouthwash
Water, sorbitol, peppermint flavor, potassium sorbate, polysorbate 80, polysorbate 20, cetylpyridinium chloride, citric acid, Blue 1 (CI 42090).

Questions?

Call toll-free 800–323–2220

Manufactured for Sage Products LLC Cary, IL

Q·Care ® Oral Cleansing and Suctioning System

Established Pharmacological Class
SubstancePharmacological Class
Mouth MoisturizerOther Oral Hygiene Products
Alcohol-Free MouthwashOther Oral Hygiene Products
QCARE ORAL CLEANSING AND SUCTIONING SYSTEM, Q2 
hydrogen peroxide kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53462-926
Packaging
#Item CodePackage Description
1NDC:53462-926-601 KIT in 1 KIT
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 14 PACKET 28 mL
Part 210 PACKET 20 g
Part 36 PACKET 42 mL
Part 1 of 3
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 
PHOSPHORIC ACID 
POLYSORBATE 80 
SACCHARIN SODIUM 
FD&C BLUE NO. 1 
FD&C YELLOW NO. 6 
Packaging
#Item CodePackage Description
14 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 3
MOUTH MOISTURIZER 
Product Information
Ingredients
Ingredient NameQuantity
COCONUT OIL 
XYLITOL 
CARBOXYMETHYLCELLULOSE SODIUM 
.ALPHA.-TOCOPHEROL ACETATE 
SPEARMINT OIL 
WATER 
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) 
POLYSORBATE 20 
POLYSORBATE 80 
POTASSIUM SORBATE 
CETYLPYRIDINIUM CHLORIDE 
Packaging
#Item CodePackage Description
110 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 3
ALCOHOL-FREE MOUTHWASH 
Product Information
Ingredients
Ingredient NameQuantity
WATER 
SORBITOL 
PEPPERMINT 
POTASSIUM SORBATE 
POLYSORBATE 80 
POLYSORBATE 20 
CITRIC ACID MONOHYDRATE 
FD&C BLUE NO. 1 
Packaging
#Item CodePackage Description
16 PACKET in 1 KIT
17 mL 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 finalpart35603/01/2014
Labeler - Sage Products, LLC (054326178)

Revised: 12/2017
 
Sage Products, LLC

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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