MULTI-ACTION ANTISEPTIC- cetylpyridinium chloride rinse 
American Sales Company

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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Multi-Action Alcohol-free antiseptic Mouth Rinse with CPC
299.005 299AK-AL

Sealed With Printed Neckband For Your Protection

Active ingredient

Cetylpyridinium Chloride 0.07%

Purpose

Antigingivitis, Antiplaque

Use

helps control plaque that leads to gingivitis

Warnings

for this product

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

Other information

Inactive ingredients

water, glycerin, flavor, poloxamer 188, sodium saccharin, propylene glycol, sodium benzoate, sucralose, benzoic acid, blue 1

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 Proctor & Gamble, distributer of Crest Pro-Health Multi-Protection Alcohol Free Rinse - Refreshing Clean Mint

DISTRIBUTED BY:

Foodhold U.S.A., LLC

Landover, MD 20785

1-877-846-9949

(c) 2018 S&S Brands, LLC

Quality guaranteed or your money back

principal display panel

CAREONE

*Compare to Crest Pro health Clean Mint*

MULTI-ACTION

ANTISEPTIC ORAL RINSE

ANTIGINGIVITIS/ANTIPLAQUE

KILLS GERMS

ALCOHOL-FREE

VIVID MINT FLAVOR

HELPS PREVENT PLAQUE

HELPS PREVENT GINGIVITIIS 

FRESHENS BREATH

33.8 FL OZ (1.05 QT) 1 L

image description

MULTI-ACTION ANTISEPTIC 
cetylpyridinium chloride rinse
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-299
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3) CETYLPYRIDINIUM CHLORIDE0.7 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLOXAMER 188 (UNII: LQA7B6G8JG)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
BENZOIC ACID (UNII: 8SKN0B0MIM)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41520-299-861000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/25/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35604/25/2018
Labeler - American Sales Company (809183973)
Registrant - Vi-Jon, LLC (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC790752542manufacture(41520-299)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC088520668manufacture(41520-299)

Revised: 2/2023
Document Id: fac09410-3b76-4517-b60f-22cb2caadd75
Set id: a0656c06-1df9-48d9-91e2-af0833f7bd75
Version: 2
Effective Time: 20230214
 
American Sales Company