QCARE ORAL CLEANSING AND SUCTIONING SYSTEM COMPATIBLE WITH 0.12% CHLORHEXIDINE GLUCONATE (CHG) ORAL RINSE- cetylpyridinium chloride kit

QCare Oral Cleansing and Suctioning System compatible with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse by

Drug Labeling and Warnings

QCare Oral Cleansing and Suctioning System compatible with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse by is a Otc medication manufactured, distributed, or labeled by Sage Products LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Suction Swab with Antiseptic Oral Rinse

Active Ingredient: Corinz™ Antiseptic Cleansing and Moisturizing Oral Rinse: Cetylpyridinium chloride 0.05%	Purpose; Antiseptic Rinse
*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 Corinz Antiseptic Cleansing and Moisturizing Oral Rinse

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

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.

INDICATIONS & USAGE

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

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.

DOSAGE & ADMINISTRATION

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 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 suctions, 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.
• Use two 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 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 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.
• Oropharyngeal Suction Catheter Non-sterile

Caution

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

Inactive Ingredients

Suction Swab with Corinz Antiseptic Cleansing and Moisturizing Oral Rinse

Water, glycerin, xylitol, spearmint flavor, potassium sorbate, polysorbate 20, polysorbate 80, hydroxyethylcellulose, citric acid, sodium saccharin, menthol.

Questions?

Call toll-free 800–323–2220

SPL UNCLASSIFIED SECTION

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

Manufactured for:
Sage Products LLC
Cary, IL 60013

1-800-323-2220

QCare Oral Cleansing & Suctioning System compatible with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse

Corinz Label

INGREDIENTS AND APPEARANCE

QCARE ORAL CLEANSING AND SUCTIONING SYSTEM COMPATIBLE WITH 0.12% CHLORHEXIDINE GLUCONATE (CHG) ORAL RINSE 
cetylpyridinium chloride kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53462-994

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53462-994-60	1 in 1 KIT; Type 1: Convenience Kit of Co-Package	11/16/2016

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	4 PACKET	28 mL  in 2
Part 2		1

Part 1 of 2

CORINZ 
cetylpyridinium chloride rinse

Product Information
Item Code (Source)	NDC: 53462-375
Route of Administration	ORAL

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
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
XYLITOL (UNII: VCQ006KQ1E)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%) (UNII: ZYD53NBL45)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		4 in 1 PACKET
1		7 mL in 1 PACKET; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	01/11/2016

Part 2 of 2

SODIUM BICARBONATE 
other oral hygiene products powder

Product Information
Route of Administration	BUCCAL

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	SODIUM BICARBONATE (UNII: 8MDF5V39QO)
INGR	CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
INGR	SODIUM LAURYL SULFATE (UNII: 368GB5141J)
INGR	SODIUM BENZOATE (UNII: OJ245FE5EU)
INGR	WATER (UNII: 059QF0KO0R)
INGR	SACCHARIN SODIUM (UNII: SB8ZUX40TY)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Cosmetic

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	11/16/2016

Labeler - Sage Products LLC (054326178)

Registrant - Sage Products LLC (054326178)

Establishment
Name	Address	ID/FEI	Business Operations
Sage Products LLC		054326178	manufacture(53462-994, 53462-375)