QCARE ORAL CLEANSING AND SUCTIONING SYSTEM, Q4- cetylpyridinium chloride and hydrogen peroxide kit

QCare Oral Cleansing and Suctioning System, Q4 by

Drug Labeling and Warnings

QCare Oral Cleansing and Suctioning System, Q4 by is a Otc medication manufactured, distributed, or labeled by Sage Products, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

• Active Ingredient: Purpose
• Hydrogen peroxide 1.5%: Oral debriding agent

Use

• Aids in the removal of secretions and debris.

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 of worsens.

KEEP OUT OF REACH OF CHILDREN

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

• 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.

DOSAGE & ADMINISTRATION

Inactive ingredients

Water, menthol flavor, polysorbate 80, phosphoric acid, sodium saccharin, Blue 1 (CI 42090), Yellow 6 (CI 15985)

Drug Facts

• Active Ingredient: Purpose
• Cetylpyridinium chloride .05%: Antigingivitis/antiplaque

Uses

Suction Toothbrush with Antiplaque Solution:

• Aids in the removal and prevention of plaque that leads to gingivitis.

Oropharyneal Suction Catheter packages:

• Aids in the removal of secretions from the oropharyngeal cavity only.

Warnings

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.

KEEP OUT OF REACH OF CHILDREN

Keep out of the 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 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 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.
• 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 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 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 practitioner.

Inactive Ingredients

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 & Suctioning System, q4 Reorder#6424

INGREDIENTS AND APPEARANCE

QCARE ORAL CLEANSING AND SUCTIONING SYSTEM, Q4 
cetylpyridinium chloride and hydrogen peroxide kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53462-424

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53462-424-60	1 in 1 KIT; Type 1: Convenience Kit of Co-Package	06/30/2008

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	4 PACKET	28 mL
Part 2	2 PACKET	14 mL
Part 3	6 PACKET	12 g
Part 4		1

Part 1 of 4

PEROX-A-MINT SOLUTION 
hydrogen peroxide mouthwash

Product Information
Item Code (Source)	NDC: 53462-075
Route of Administration	BUCCAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V)	HYDROGEN PEROXIDE	15 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PHOSPHORIC ACID (UNII: E4GA8884NN)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		4 in 1 KIT
1	NDC: 53462-075-60	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

Part 2 of 4

ANTIPLAQUE SOLUTION 
cetylpyridinium chloride mouthwash

Product Information
Item Code (Source)	NDC: 53462-275
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
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
PEPPERMINT (UNII: V95R5KMY2B)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		2 in 1 KIT
1	NDC: 53462-275-60	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	01/09/2009

Part 3 of 4

MOUTH MOISTURIZER 
other oral hygiene products

Product Information

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	COCONUT OIL (UNII: Q9L0O73W7L)
INGR	XYLITOL (UNII: VCQ006KQ1E)
INGR	CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
INGR	.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
INGR	SPEARMINT OIL (UNII: C3M81465G5)
INGR	WATER (UNII: 059QF0KO0R)
INGR	CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)
INGR	POLYSORBATE 20 (UNII: 7T1F30V5YH)
INGR	POLYSORBATE 80 (UNII: 6OZP39ZG8H)
INGR	POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
INGR	CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		6 in 1 KIT
1		2 g in 1 PACKET; Type 0: Not a Combination Product

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

Part 4 of 4

SODIUM BICARBONATE 
other oral hygiene products

Product Information

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	06/30/2008

Labeler - Sage Products, LLC (054326178)