QCARE ORAL CLEANSING AND SUCTIONING SYSTEM COMPATIBLE WITH 0.12% CHLORHEXIDINE GLUCONATE (CHG) ORAL RINSE- 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 compatible with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse

Drug Facts

Suction Swab with Antiseptic Oral Rinse

Active Ingredient:

Corinz™ Antiseptic Cleansing and Moisturizing Oral Rinse:

Cetylpyridinium chloride 0.05%

Purpose
Antiseptic Rinse
*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 Corinz Antiseptic Cleansing and Moisturizing Oral Rinse

Suction Toothbrush CHG compatible*

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

Suction Swab with Antiseptic Oral Rinse
Before opening, turn package over, burst solution packet with thumbs.


Suction Toothbrush CHG compatible*


Oropharyngeal Suction Catheter Non-sterile

Caution

Inactive Ingredients

Suction Swab with Corinz Antiseptic Cleansing and Moisturizing Oral Rinse


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

Questions?

Call toll-free 800–323–2220

NOT MADE WITH NATURAL RUBBER LATEX • FOR SINGLE USE ONLY • MADE IN U.S.A.

Manufactured for:
Sage Products LLC
Cary, IL 60013

1-800-323-2220

QCare Oral Cleansing & Suctioning System compatible with 0.12% Chlorhexidine Gluconate (CHG) Oral Rinse

6994 Bag Label

6994 Film6994 Blister Label

Corinz Label

Corinz Label

QCARE ORAL CLEANSING AND SUCTIONING SYSTEM COMPATIBLE WITH 0.12% CHLORHEXIDINE GLUCONATE (CHG) ORAL RINSE 
cetylpyridinium chloride kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53462-994
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53462-994-601 in 1 KIT; Type 1: Convenience Kit of Co-Package11/16/2016
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 14 PACKET 28 mL  in 2 
Part 2
Part 1 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 CHLORIDE0.5 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
14 in 1 PACKET
17 mL in 1 PACKET; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35601/11/2016
Part 2 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
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35611/16/2016
Labeler - Sage Products LLC (054326178)
Registrant - Sage Products LLC (054326178)
Establishment
NameAddressID/FEIBusiness Operations
Sage Products LLC054326178manufacture(53462-994, 53462-375)

Revised: 10/2019
Document Id: 9596c853-ac54-f873-e053-2a95a90a6823
Set id: 69dc3f73-5992-45d2-95cc-3ba5dd40b470
Version: 3
Effective Time: 20191023
 
Sage Products LLC