QCare Petite Size Oral Cleansing and Suctioning System

Drug Labeling and Warnings

Drug Details [pdf]

QCARE PETITE SIZE ORAL CLEANSING AND SUCTIONING SYSTEM- cetylpyridinium chloride 
Sage Products LLC

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.

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QCare Petite Size Oral Cleansing and Suctioning System

Drug Facts

• Active Ingredient: ANTISEPTIC ORAL RINSE: Purpose
• Cetylpyridinium chloride .05%: Antiseptic Rinse

Uses

Suction Swab

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

Suction Toothbrush

• 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.
• 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.
• Use up to 4 times daily or as directed by a dentist or doctor.
• Children under 6 years of age to 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 with Antiseptic Oral Rinse

• Before opening, turn package over, burst solution packet with thumbs.
• Peel lid to open.
• 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.
• 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.

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

QCare Petite Size Oral Cleansing and Suctioning System

QCARE PETITE SIZE ORAL CLEANSING AND SUCTIONING SYSTEM 
cetylpyridinium chloride kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53462-014

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53462-014-60	1 in 1 KIT; Type 1: Convenience Kit of Co-Package	10/26/2017

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	6 PACKET	42 mL  in 6

Part 1 of 1

ANTISEPTIC ORAL RINSE 
cetylpyridinium chloride mouthwash

Product Information
Item Code (Source)	NDC: 53462-175
Route of Administration	BUCCAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3)	CETYLPYRIDINIUM CHLORIDE	0.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
SORBITOL (UNII: 506T60A25R)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		6 in 1 KIT
1	NDC: 53462-175-60	7 mL in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	05/21/1998

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	10/26/2017	10/10/2018

Labeler - Sage Products LLC (054326178)

Registrant - Sage Products LLC (054326178)

Establishment
Name	Address	ID/FEI	Business Operations
Sage Products LLC		054326178	manufacture(53462-014, 53462-175)

Revised: 6/2019

Document Id: 8bb01611-1208-4e49-e053-2a95a90a7f85

34390-5

Set id: de15b90c-e37c-4cb5-a0b4-623733fc607f

Version: 3

Effective Time: 20190619