QCARE ORAL CLEANSING AND SUCTIONING SYSTEM- cetylpyridinium chloride 
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 & Suctioning System Corinz™ Antiseptic Cleansing and Moisturizing Oral Rinse

Drug Facts

Active ingredient: Purpose
Corinz™ Antiseptic Cleansing and Moisturizing Oral Rinse:
Cetylpyridinium chloride 0.05%Antiseptic Rinse

Uses

Oropharyngeal Suction Catheter Non-sterile

Warnings

Stop use and ask a doctor if:

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.

Directions

Toothette Oral Care Suction Toothbrush

Toothette Oral Care Suction Swab

Oropharyngeal Suction Catheter Non-sterile

Inactive ingredients

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

Questions?

Call toll-free 800-323-2220.

LATEX FREE FOR SINGLE USE ONLY MADE IN U.S.A.

Corinz Label

corinz-label

QCARE ORAL CLEANSING AND SUCTIONING SYSTEM

r4735-6462-bag
r4736-6464-bag
r5477-6462-film
QCARE ORAL CLEANSING AND SUCTIONING SYSTEM 
cetylpyridinium chloride kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53462-462
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53462-462-601 in 1 KIT; Type 4: Device Coated/Impregnated/Otherwise Combined with Drug01/11/2016
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 1
Part 212 POUCH 84 mL  in 12 
Part 1 of 2
SODIUM BICARBONATE 
other oral hygiene products powder
Product Information
Route of AdministrationBUCCAL
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRSODIUM BICARBONATE (UNII: 8MDF5V39QO)  
INGRCARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
INGRSODIUM LAURYL SULFATE (UNII: 368GB5141J)  
INGRSODIUM BENZOATE (UNII: OJ245FE5EU)  
INGRWATER (UNII: 059QF0KO0R)  
INGRSACCHARIN SODIUM (UNII: SB8ZUX40TY)  
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Cosmetic
Part 2 of 2
CORINZ 
cetylpyridinium chloride rinse
Product Information
Item Code (Source)NDC:53462-375
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3) CETYLPYRIDINIUM CHLORIDE.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
112 in 1 PACKET
17 mL in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35601/11/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35601/11/2016
QCARE ORAL CLEANSING AND SUCTIONING SYSTEM 
cetylpyridinium chloride kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53462-464
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53462-464-601 in 1 KIT; Type 4: Device Coated/Impregnated/Otherwise Combined with Drug01/11/2016
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 1
Part 26 POUCH 42 mL  in 6 
Part 1 of 2
SODIUM BICARBONATE 
other oral hygiene products powder
Product Information
Route of AdministrationBUCCAL
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRSODIUM BICARBONATE (UNII: 8MDF5V39QO)  
INGRCARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
INGRSODIUM LAURYL SULFATE (UNII: 368GB5141J)  
INGRSODIUM BENZOATE (UNII: OJ245FE5EU)  
INGRWATER (UNII: 059QF0KO0R)  
INGRSACCHARIN SODIUM (UNII: SB8ZUX40TY)  
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Cosmetic
Part 2 of 2
CORINZ 
cetylpyridinium chloride rinse
Product Information
Item Code (Source)NDC:53462-375
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3) CETYLPYRIDINIUM CHLORIDE.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
16 in 1 PACKET
17 mL in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35601/11/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35601/11/2016
Labeler - Sage Products LLC (054326178)
Registrant - Sage Products LLC (054326178)
Establishment
NameAddressID/FEIBusiness Operations
Sage Products LLC054326178MANUFACTURE(53462-464, 53462-375, 53462-462)

Revised: 1/2016
Document Id: 08560105-d7fc-334e-08a1-73c0f1f93b7b
Set id: 08560105-d7fc-334e-08a1-73c0f1f93b7b
Version: 1
Effective Time: 20160129
 
Sage Products LLC