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

Active Ingredient: PEROX-A-MINT:Purpose
Hydrogen Peroxide 1.5%Oral Debriding Agent
Active Ingredient: ANTIPLAQUE*:Purpose
Cetylpyridinium chloride .05%Antigingivitis/antiplaque

USES

Suction Swab with Perox-A-Mint Solution:

Suction Toothbrush with Antiplaque Solution:

WARNINGS

Suction Swab with Perox-A-Mint Solution:

Stop use and ask a doctor if:

Suction Toothbrush with Antiplaque Solution:

Stop use and ask a dentist if:

Suction Swab with Perox-A-Mint Solution:
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.

Suction Toothbrush with Antiplaque Solution:
Keep out of 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 Swab with Perox-A-Mint Solution:

Suction Toothbrush with Antiplaque Solution:

Inactive Ingredients

Suction Swab with Perox-A-Mint Solution:
Water, menthol flavor, polysorbate 80, phosphoric acid, sodium saccharin, Blue 1 (CI 42090), Yellow 6 (CI 15985)

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

Q·Care® Oral Cleansing and Suctioning System

R4699B_6504_bag1

Q·Care® Oral Cleansing and Suctioning System Label

R6037_6504_overlabel2

Q-Care® Oral Cleansing and Suctioning System, q4°

R5427_top_web_film_6504
QCARE ORAL CLEANSING AND SUCTIONING SYSTEM, Q4 
cetylpyridinium chloride and hydrogen peroxide kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53462-504
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53462-504-601 in 1 KIT
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 POUCH 7 mL
Part 21 POUCH 7 mL
Part 1 of 2
TOOTHETE ORAL CARE SUCTION SWAB WITH PEROX-A-MINT SOLUTION 
hydrogen peroxide mouthwash
Product Information
Route of AdministrationBUCCAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) HYDROGEN PEROXIDE15 [iU]  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
11 in 1 PACKAGE
12 in 1 PACKET
17 mL in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35605/21/1998
Part 2 of 2
SUCTION TOOTHBRUSH WITH ANTIPLAQUE SOLUTION 
cetylpyridinium chloride mouthwash
Product Information
Route of AdministrationBUCCAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3) CETYLPYRIDINIUM CHLORIDE.5 [iU]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
11 in 1 PACKAGE
12 in 1 PACKET
17 mL in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35605/21/1998
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35605/21/1998
Labeler - Sage Products LLC (054326178)
Registrant - Sage Products LLC (054326178)
Establishment
NameAddressID/FEIBusiness Operations
ChemRite CoPac, Inc.623776502MANUFACTURE(53462-504)
Establishment
NameAddressID/FEIBusiness Operations
Sage Products LLC054326178MANUFACTURE(53462-504)

Revised: 8/2013
Document Id: 207b8fdf-4f03-69b8-4621-b8054b7ae6a6
Set id: 207b8fdf-4f03-69b8-4621-b8054b7ae6a6
Version: 1
Effective Time: 20130820
 
Sage Products LLC