PERIACTIVE- sambucus nigra flower, echinacea purpurea, and centella asiatica mouthwash

PeriActive by

Drug Labeling and Warnings

PeriActive by is a Homeopathic medication manufactured, distributed, or labeled by Izun Pharmaceuticals Corp. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts:

ACTIVE INGREDIENT

Active Ingredients (in each 15ml)	Purposes
Sambucus nigra 3x	Irritation/gingivitis reducer; gum repair stimulator
Echinacea purpurea 4x	Irritation/gingivitis reducer
Hydrocotyle asiatica 4x	Irritation/gingivitis reducer

Uses

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

Warnings

Allergy alert

Do not use if allergic to any of the ingredients. 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 gum line, loose teeth, or increasing spacing between the teeth. These may be the signs of periodontitis, a serious form of gum disease.

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

• do not eat, drink or rinse your mouth for 30 minutes after use
• do not swallow
• children 6 years to under 12 years of age: supervise use

Other information

This rinse is not intended to replace brushing or flossing

• store at room temperature 15-30°C (59-86°F)
• keep out of direct sunlight

Inactive ingredients

cetylpyridinium chloride, cool mint flavor1, disodium EDTA, FD&C Blue No. 1 ,lactic acid, maltodextrin, menthol, nat. cinnamon flavor1, PEG-40 hydrogenated castor oil, propylene glycol, sodium benzoate, sorbitol, sucralose, water, wintergreen flavor1

1 contains one or more of these ingredients

Questions?

Call 1-800-956-2595

SPL UNCLASSIFIED SECTION

Distributed By: straumann
Institut Straumann AG
Peter Merian-Weg 12 | 4002 Basel | Switzerland

PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label

PeriACTIVE®

DISTRIBUTED BY STRAUMANN

ADVANCED GUM CARE

ORAL RINSE

Powered by Nature

CLINICALLY PROVEN
to Reduce Inflammation

KILLS BACTERIA

REDUCES
Gum Bleeding & Soreness

PROTECTS
Against Plaque & Gingivitis

Fresh Mint

HOMEOPATHIC

500 mL e (16.9 fl. oz.)

INGREDIENTS AND APPEARANCE

PERIACTIVE 
sambucus nigra flower, echinacea purpurea, and centella asiatica mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49589-199
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Sambucus nigra flower (UNII: 07V4DX094T) (Sambucus nigra flower - UNII:07V4DX094T)	Sambucus nigra flower	3 [hp_X]  in 1 mL
Echinacea purpurea (UNII: QI7G114Y98) (Echinacea purpurea - UNII:QI7G114Y98)	Echinacea purpurea	4 [hp_X]  in 1 mL
Centella asiatica (UNII: 7M867G6T1U) (Centella asiatica - UNII:7M867G6T1U)	Centella asiatica	4 [hp_X]  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
cetylpyridinium chloride (UNII: D9OM4SK49P)
edetate disodium (UNII: 7FLD91C86K)
LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)
maltodextrin (UNII: 7CVR7L4A2D)
polyoxyl 40 hydrogenated castor oil (UNII: 7YC686GQ8F)
propylene glycol (UNII: 6DC9Q167V3)
sodium benzoate (UNII: OJ245FE5EU)
sorbitol (UNII: 506T60A25R)
sucralose (UNII: 96K6UQ3ZD4)
water (UNII: 059QF0KO0R)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49589-199-50	12 in 1 CARTON	02/01/2019
1		500 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 49589-199-10	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED HOMEOPATHIC		02/01/2019

Labeler - Izun Pharmaceuticals Corp (624194523)