QCARE ORAL CLEANSING AND SUCTIONING SYSTEM, Q4- hydrogen peroxide 
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 Oral Cleansing and Suctioning System, Q4

Drug Facts

Suction Swab with Perox-A-Mint Solution
Active Ingredient: PEROX-A-MINT: Purpose
Hydrogen Peroxide 1.5%Oral Debriding Agent
*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 Perox-A-Mint Solution

  • Aids in the removal of secretions and debris.

Suction Toothbrush CHG compatible*

  • Aids in the removal of dental plaque, debris and secretions.

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 debriding is accidentally swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS

Suction Swab with Perox-A-Mint Solution

  • 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 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 Handle.
  • Suction secretions from the oropharyngeal cavity.
  • To suction, slide switch to ON. When finished, return switch to OFF.
  • To clear tubing, rinse with sterile saline or appropriate solution.
  • Discard Suction Catheter. Reattach Covered Yankauer to Suction Handle.
  • Use a 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 practicioner.

Inactive Ingredients

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

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 and Suctioning System, Q4

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Perox-A-Mint Solution

Perox-A-Mint

QCARE ORAL CLEANSING AND SUCTIONING SYSTEM, Q4 
hydrogen peroxide kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53462-927
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53462-927-601 in 1 KIT; Type 1: Convenience Kit of Co-Package03/01/201404/09/2018
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 14 PACKET 28 mL
Part 24 PACKET 8 g
Part 3
Part 1 of 3
PEROX-A-MINT SOLUTION 
hydrogen peroxide mouthwash
Product Information
Item Code (Source)NDC:53462-075
Route of AdministrationBUCCAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) HYDROGEN PEROXIDE15 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
14 in 1 KIT
1NDC:53462-075-607 mL in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35605/21/1998
Part 2 of 3
MOUTH MOISTURIZER 
other oral hygiene products
Product Information
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRCOCONUT OIL (UNII: Q9L0O73W7L)  
INGRXYLITOL (UNII: VCQ006KQ1E)  
INGRCARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
INGR.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
INGRWATER (UNII: 059QF0KO0R)  
INGRPOLYSORBATE 20 (UNII: 7T1F30V5YH)  
INGRPOLYSORBATE 80 (UNII: 6OZP39ZG8H)  
INGRPOTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
INGRCETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
INGRCARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
14 in 1 KIT
12 g in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Cosmetic
Part 3 of 3
SODIUM BICARBONATE 
other oral hygiene products
Product Information
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRSODIUM BICARBONATE (UNII: 8MDF5V39QO)  
INGRCARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
INGRSODIUM BENZOATE (UNII: OJ245FE5EU)  
INGRWATER (UNII: 059QF0KO0R)  
INGRSACCHARIN SODIUM (UNII: SB8ZUX40TY)  
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 finalpart35603/01/201404/09/2018
Labeler - Sage Products, LLC (054326178)

Revised: 4/2018
 
Sage Products, LLC