MASTIKIS FRESH GARGLE- cetylpyridinium chloride mouthwash 
Mastic Korea.Co.Ltd

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.

----------

79814-007_Mastikis fresh gargle

Active ingredient

Cetylpyridinium chloride 0.05%

Purpose

Antigingivitis, Antiplaque

Use

helps control plaque that leads to gingivitis

Warnings

Ask a dentist before use if
- gingivitis, bleeding, or redness persists for more than 2 weeks
- you have painful or swollen gums, pus from the gum line, loose teeth or increased spacing between the teeth. These may be signs of symptoms of periodontitis, a serious form of gum disease.

Stop use and ask a dentist if

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

Glycerin, Xylitol, Steviol Glycoside, Trisodium Citrate, Ascorbic Acid, L-Menthol, Green Tea Extract, Mastic Oil, Lemon Mint Flavor, Sodium Benzoate, Hydrogenated Caster Oil, Deionized Water

principal display panel

image description

MASTIKIS FRESH GARGLE 
cetylpyridinium chloride mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79814-007
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3) CETYLPYRIDINIUM CHLORIDE0.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
XYLITOL (UNII: VCQ006KQ1E)  
STEVIOSIDE (UNII: 0YON5MXJ9P)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
LEVOMENTHOL (UNII: BZ1R15MTK7)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79814-007-0220 in 1 PACKAGE09/21/2020
1NDC:79814-007-0110 mL in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35609/21/2020
Labeler - Mastic Korea.Co.Ltd (687791189)
Registrant - Mastic Korea.Co.Ltd (687791189)
Establishment
NameAddressID/FEIBusiness Operations
Sungwon Pharmaceutical Co., Ltd.689787898manufacture(79814-007)

Revised: 9/2020
Document Id: afdb2128-4154-446d-e053-2a95a90a0af7
Set id: 9bb4f058-52ef-46fc-bd2e-a57b8ac6ace2
Version: 1
Effective Time: 20200921
 
Mastic Korea.Co.Ltd