QCARE PETITE SIZE ORAL CLEANSING AND SUCTIONING SYSTEM- cetylpyridinium chloride kit

QCare Petite Size Oral Cleansing and Suctioning System by

Drug Labeling and Warnings

QCare Petite Size Oral Cleansing and Suctioning System 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: 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.

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 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

INGREDIENTS AND APPEARANCE

QCARE PETITE SIZE ORAL CLEANSING AND SUCTIONING SYSTEM 
cetylpyridinium chloride kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53462-714

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53462-714-60	1 in 1 KIT; Type 1: Convenience Kit of Co-Package	04/02/2013

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	6 PACKET	42 mL  in 6
Part 2	6 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 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

Part 2 of 2

MOUTH MOISTURIZER 
other oral hygiene products emulsion

Product Information
Route of Administration	BUCCAL

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	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

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	04/02/2013

Labeler - Sage Products, LLC (054326178)