Your browser does not support JavaScript! QCARE (CETYLPYRIDINIUM CHLORIDE) KIT [SAGE PRODUCTS, INC.]
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QCARE (cetylpyridinium chloride) kit
[Sage Products, Inc.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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.
Drug Label Sections

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:

  • Sore mouth symptoms do not improve in 7 days.
  • Swelling, rash or fever develops.
  • Irritation, pain, or redness persists or worsens.

Directions

  • Use up to 4 times daily or as directed by a dentist or doctor.
  • Children under 12 years of age:  supervise use
  • Children under 3 years of age:  consult a dentist or doctor.
  • Use a bite block when performing oral care on patients with altered levels of consciousness or those who cannot comprehend commands.
  • Ensure foam is intact after use.  If not, remove any particles from oral cavity.

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
 
Sage Products, Inc.

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