PERIACTIVE MOUTHWASH- sambucus nigra flower extract, centella asiatica leaf extract, echinacea purpurea extract mouthwash 
Incos Cosmeceutica Industriale Srl

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Periactive Mouthwash

Active ingredient

Sambucus nigra flower extract, 3x

Centella Asiatica Leaf Extract, 4x

Echinacea Purpurea Extract, 4x

Inactive Ingredients:

Aqua, Propylene Glycol, Sorbitol, PEG-40 Hydrogenated Castor Oil, Cetylpyridinum Chloride, Lactic Acid, Sodium Benzoate, Disodium EDTA, Maltodextrin, Sucralose, CI 42090, Aroma

Irritation / gingivitus reducer / gum repair reducer

Keep out of reach of children under 6 years of age. In case more than is used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

Adults and children 12 years and olderrinse for 60 seconds with 15 ml (3 teaspoonful twice a day)
children 6-12 years rinse for 60 seconds with 10 ml (2 teaspoonful twice a day)
children under 6 years of age do not use

Uses

Helps protect against gingivitis
Helps reduce gum bleeding and soreness
Helps reduce plaque formation
Helps reduce gum inflammation
Promotes gingival healing

Allergy Alert

Do not use if allergic to any of the ingredients. Stop use and ask a dentist if:

image label

PERIACTIVE MOUTHWASH 
sambucus nigra flower extract, centella asiatica leaf extract, echinacea purpurea extract mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72549-000
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CENTELLA ASIATICA LEAF (UNII: 6810070TYD) (CENTELLA ASIATICA LEAF - UNII:6810070TYD) CENTELLA ASIATICA LEAF4 [hp_X]  in 1 mL
ECHINACEA PURPUREA (UNII: QI7G114Y98) (ECHINACEA PURPUREA - UNII:QI7G114Y98) ECHINACEA PURPUREA4 [hp_X]  in 1 mL
SAMBUCUS NIGRA FLOWER (UNII: 07V4DX094T) (SAMBUCUS NIGRA FLOWER - UNII:07V4DX094T) SAMBUCUS NIGRA FLOWER3 [hp_X]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM BENZOATE (UNII: OJ245FE5EU)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
LACTIC ACID (UNII: 33X04XA5AT)  
BRILLIANT BLUE G (UNII: M1ZRX790SI)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
Product Characteristics
ColorblueScore    
ShapeSize
FlavorWINTERGREENImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72549-000-01500 mL in 1 TUBE; Type 0: Not a Combination Product01/31/2019
2NDC:72549-000-0275 mL in 1 TUBE; Type 0: Not a Combination Product01/31/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other08/24/2018
Labeler - Incos Cosmeceutica Industriale Srl (434933032)
Establishment
NameAddressID/FEIBusiness Operations
Incos Cosmeceutica Industriale Srl434933032manufacture(72549-000)

Revised: 1/2019
Document Id: 80c01012-4415-8cae-e053-2a91aa0a0e27
Set id: 80c01012-4414-8cae-e053-2a91aa0a0e27
Version: 1
Effective Time: 20190131
 
Incos Cosmeceutica Industriale Srl