ANTISEPTIC- cetylpyridinium chloride rinse

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3)

Available from:

Topco Associates LLC

INN (International Name):

CETYLPYRIDINIUM CHLORIDE

Composition:

CETYLPYRIDINIUM CHLORIDE 0.7 mg in 1 mL

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

helps control plaque that leads to gingivitis

Authorization status:

OTC monograph not final

Summary of Product characteristics

ANTISEPTIC- CETYLPYRIDINIUM CHLORIDE RINSE
TOPCO ASSOCIATES 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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TOPCARE ANTISEPTIC MOUTHRINSE
299.005/295AK/AL
ACTIVE INGREDIENT
Cetylpyridinium chloride 0.07%
PURPOSE
Antigingivitis, Antiplaque
USE
helps control plaque that leads to gingivitis
WARNINGS
for this product only
STOP USE AND ASK A DENTIST IF
gingivitis, bleeding or redness persists for more than 2 weeks
you have painful or swollen gums, pus from the gun line, loose teeth
or increased
spacing between the teeth. These may be signs or symptoms of
periodontitis, a
serious form of gum disease.
KEEP OUT OF REACH OF CHILDREN UNDER 6 YEARS OF AGE.
If more than used for rinsing is accidentally swallowed, get medical
help or contact a
Poison Control center right away.
DIRECTIONS
adults and children 6 years & older: rinse for 30 seconds with 20 mL
(4 teaspoonfuls)
twice a day
do not swallow
children 6 years to under 12 years of age: supervise use
children under 6 years of age: do not use
OTHER INFORMATION
this rinse is not intended to replace brushing or flossing
INACTIVE INGREDIENTS
water, glycerin, flavor, poloxamer 188, sodium saccharin, propylene
glycol, sodium
benzoate, sucralose, benzoic acid, blue 1
QUESTIONS?
Call 1-888-423-0139
SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION
TopCare everyday
Kills germs for better oral hygiene
Helps reduce plaque bacteria
Helps prevent gingivitis
Freshens breath
This rinse may cause temporary staining to the surface of teeth.
This is not harmful, and adequate brushing may prevent its occurence
*This product is not manufactured or distributed by Procter & Gamble
distributor of
Crest Pro-Health Multi-Protection Alcohol Free Rinse-Refreshing Clean
Mint
DISTRIBUTED BY TOPCO ASSOCIATES, LLC
ELK GROOVE VILLAGE, IL 60077
QUESTIONS? 1-888-423-0139
[e-mail] www.topcarebrand.com
This Top Care product