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QCare Petite Size Oral Cleansing and Suctioning System

Medically reviewed on December 28, 2017

Dosage form: kit
Ingredients: CETYLPYRIDINIUM CHLORIDE 0.5mg in 1mL;
Labeler: Sage Products, LLC
NDC Code: 53462-714

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 Petite Size Oral Cleansing and Suctioning System

Drug Facts
Suction Swab, Petite Size, with Antiseptic Oral Rinse/Suction Toothbrush, Petite Size, with Antiseptic Oral Rinse
Active Ingredient:
ANTISEPTIC ORAL RINSE:
Purpose
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.

Suction Toothbrush with Antiseptic Oral Rinse

  • Aids in the removal of dental plaque, secretions, and debris; helps reduce the chance of infection in minor oral irritation.

Oropharyngeal Suction Catheter

  • 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 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 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.
  • 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

  • Peel lid to open.
  • Attach Suction Catheter to suction line.
  • 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.

CAUTION:

  • Federal (USA) law restricts this device to sale by or on the order of a physician or licensed practitioner.

Inactive Ingredients

Water, sorbitol, mentha piperita (peppermint) extract, potassium sorbate, polysorbate 80, polysorbate 20, citric acid, Blue 1 (CI 42090)

Questions?

Call toll-free 800-323-2220.

Mouth Moisturizer ingredients*

Water, cocos nucifera (coconut) oil, xylitol, flavor, cellulose gum, tocopheryl acetate (vitamin E), mentha veridis (spearmint) leaf oil, carbomer, polysorbate 20, polysorbate 80, potassium sorbate, cetylpyridinium chloride

* Manufactured for Sage Products LLC • Cary, IL

www.sageproducts.com/patents

NOT MADE WITH NATURAL RUBBER LATEX • FOR SINGLE USE ONLY • MADE IN USA

QCare Petite Size Oral Cleansing and Suctioning System

Antiseptic Oral Rinse Solution

Established Pharmacological Class
SubstancePharmacological Class
Mouth MoisturizerOther Oral Hygiene Products
QCARE PETITE SIZE ORAL CLEANSING AND SUCTIONING SYSTEM 
cetylpyridinium chloride kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53462-714
Packaging
#Item CodePackage Description
1NDC:53462-714-601 KIT in 1 KIT
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 16 PACKET 42 mL  in 6 
Part 26 PACKET 12 g  in 6 
Part 1 of 2
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
SORBITOL 
POTASSIUM SORBATE 
POLYSORBATE 80 
POLYSORBATE 20 
CITRIC ACID MONOHYDRATE 
FD&C BLUE NO. 1 
WATER 
Packaging
#Item CodePackage Description
16 PACKET in 1 KIT
1NDC:53462-175-607 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 2
MOUTH MOISTURIZER 
mouth moisturizer emulsion
Product Information
Route of AdministrationBUCCALDEA Schedule    
Ingredients
Ingredient NameQuantity
COCONUT OIL 
XYLITOL 
CARBOXYMETHYLCELLULOSE SODIUM 
.ALPHA.-TOCOPHEROL ACETATE 
WATER 
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) 
POLYSORBATE 20 
POLYSORBATE 80 
POTASSIUM SORBATE 
CETYLPYRIDINIUM CHLORIDE 
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 finalpart35604/02/2013
Labeler - Sage Products, LLC (054326178)

 
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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