OLIO ACTIV MOUTHWASH CINNAMON- cetylpyridinium chloride liquid 
Kleen Test Products Corporation

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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olio activ mouthwash cinnamon

Active ingredient

Cetylpyridinium Chloride 0.05%

Purpose

Antigingivitis/Antiplaque

Use

  • helps prevent gingivitis and bleeding gums
  • helps control plaque that leads to gingivitis, an early form of gum disease

Warnings

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

Keep out of reach of children under 6 years of age.

Directions

  • Adults and children 12 years of age and older:
  • Shake bottle vigorously before use to activate mouthwash
  • Use twice a day after brushing your teeth with toothpaste
  • Swish and gargle 20 ml (1 cap) of rinse between your teeth for 30 seconds and then spit out
  • Do not swallow the rinse
  • Do not eat or drink for 30 minutes after rinsing
  • Children 6-12 years of age:supervise use
  • Children under 6 years of age: do not use

Other Information

Bottle needs to be shaken each time it is used. Separation, cloudiness, and foaming are normal with this product. Cold temperature may cause cloudiness. Store at room temp (68°-77°F). Oral bacteria and debris may be visible in your sink after spitting out.

Inactive Ingredients

water, isopropyl myristate, sorbitol, propylene glycol, flavor, sodium saccharine, sucrolose, sodium benzoate, sodium phosphate, triclosan, citric acid, red #33, yellow #5, blue #1

Questions?

Call 1-855-545-4208

Package Label

image description

OLIO ACTIV MOUTHWASH  CINNAMON
cetylpyridinium chloride liquid
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:55239-001
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETYLPYRIDINIUM CHLORIDE (CETYLPYRIDINIUM) CETYLPYRIDINIUM CHLORIDE0.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
water 
ISOPROPYL MYRISTATE 
SORBITOL 
PROPYLENE GLYCOL 
SUCRALOSE 
SODIUM BENZOATE 
SODIUM PHOSPHATE 
TRICLOSAN 
CITRIC ACID MONOHYDRATE 
D&C RED NO. 33 
FD&C YELLOW NO. 5 
FD&C BLUE NO. 1 
Product Characteristics
Color    Score    
ShapeSize
FlavorCINNAMON (cinnamon) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55239-001-00500 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35607/09/201401/28/2015
Labeler - Kleen Test Products Corporation (168165814)
Registrant - Kleen Test Products Corporation (168165814)
Establishment
NameAddressID/FEIBusiness Operations
Kleen Test Products Corporation168165814manufacture(55239-001)

Revised: 1/2015
 
Kleen Test Products Corporation