QCARE- 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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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

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

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.

Bag Label

Bag Label
Film Label

Burst Pouch
QCARE 
cetylpyridinium chloride kit
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:53462-306
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:53462-306-60 1 in 1 KIT; Type 4: Device Coated/Impregnated/Otherwise Combined with Drug
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 4 POUCH 28 mL
Part 1 of 1
CORINZ 
cetylpyridinium chloride rinse
Product Information
Item Code (Source) NDC:53462-375
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3) CETYLPYRIDINIUM CHLORIDE .5 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
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 Code Package Description Marketing Start Date Marketing End Date
1 1 in 1 PACKET
1 7 mL in 1 POUCH
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part356 12/28/2001
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part356 12/28/2001
QCARE 
cetylpyridinium chloride kit
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:53462-308
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:53462-308-60 1 in 1 KIT; Type 4: Device Coated/Impregnated/Otherwise Combined with Drug
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 3 POUCH 21 mL
Part 1 of 1
CORINZ 
cetylpyridinium chloride rinse
Product Information
Item Code (Source) NDC:53462-375
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3) CETYLPYRIDINIUM CHLORIDE .5 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
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 Code Package Description Marketing Start Date Marketing End Date
1 1 in 1 PACKET
1 7 mL in 1 POUCH
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part356 12/28/2001
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part356 12/28/2001
Labeler - Sage Products LLC (054326178)
Registrant - Sage Products LLC (054326178)
Establishment
Name Address ID/FEI Business Operations
Sage Products LLC 054326178 MANUFACTURE(53462-308, 53462-306)

Revised: 3/2015
Document Id: 77cd666b-f9c1-4d44-b1c8-6de5cc1d299d
Set id: d56b7b37-f818-4e7f-9443-3bf7e5a530ee
Version: 2
Effective Time: 20150305
 
Sage Products LLC