QCARE- cetylpyridinium chloride   
Sage Products, Inc.

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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Drug Facts

Cetylpyridinium chloride .05%

Antiseptic rinse

If more than used for antisepsis is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Aids in the removal of secretions and debris and helps reduce the chance of infection in minor oral irritation.

Stop use and ask a doctor if:

Directions

water, sorbitol, peppermint flavor, potassium sorbate, polysorbate 80, polysorbate 20, citric acid, Blue 1 (CI 42090).


Sodium Bicarbonate ingredients:  Water, sodium bicarbonate, sodium carboxymethyl cellulose, sodium lauryl sulfate, flavor, sodium sacharin, sodium benzoate.


Mouth Moisturizer ingredients:  Water, coconut oil, xylitol, spearmint flavor, sodium carboxymethyl cellulose, tocopheryl acetate (vitamin E), spearmint oil, carbomer, polysorbate 20, polysorbate 80, potassium sorbate, cetylpyridinium chloride.

outer bag

top web film

top web film backside

QCARE 
cetylpyridinium chloride kit
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:53462-308
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53462-308-601 in 1 KIT
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 13 PACKET 21 mL
Part 1 of 1
QCARE 
cetylpyridinium chloride rinse
Product Information
Item Code (Source)NDC:53462-175
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
cetylpyridinium chloride (cetylpyridinium) cetylpyridinium chloride0.5 ug  in 1 mL
Inactive Ingredients
Ingredient NameStrength
water 
sorbitol 
peppermint 
potassium sorbate 
polysorbate 80 
polysorbate 20 
citric acid monohydrate 
FD&C Blue No. 1 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
11 in 1 POUCH
1NDC:53462-175-607 mL in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35612/28/2012
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35612/28/2001
QCARE 
cetylpyridinium chloride kit
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:53462-306
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53462-306-601 in 1 KIT
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 14 PACKET 28 mL
Part 1 of 1
QCARE 
cetylpyridinium chloride rinse
Product Information
Item Code (Source)NDC:53462-175
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
cetylpyridinium chloride (cetylpyridinium) cetylpyridinium chloride0.5 ug  in 1 mL
Inactive Ingredients
Ingredient NameStrength
water 
sorbitol 
peppermint 
potassium sorbate 
polysorbate 80 
polysorbate 20 
citric acid monohydrate 
FD&C Blue No. 1 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
11 in 1 POUCH
1NDC:53462-175-607 mL in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35612/28/2001
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35612/28/2001
Labeler - Sage Products, Inc. (054326178)
Establishment
NameAddressID/FEIBusiness Operations
Sage Products, Inc.054326178MANUFACTURE(53462-308, 53462-306)

Revised: 8/2012
Document Id: 24000dad-f2d5-5b11-0958-c12e044e71ea
Set id: d56b7b37-f818-4e7f-9443-3bf7e5a530ee
Version: 1
Effective Time: 20120802
 
Sage Products, Inc.