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 Pharmaceutical Corporation, Abaco Partners LLC DBA Surefil. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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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
• do not use if tab is broken, breached or missing

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 1-877-210-2621 Monday thru Friday 8am-5pm EST

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Distributed by: Izun Oral Care, Inc., New York, NY 10020 USA

PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label

PeriACTIVE®

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

Safety-sealed for your protection.
500 mL (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: 49589-111
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49589-111-50	12 in 1 CARTON	01/11/2009
1		500 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 49589-111-10	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED HOMEOPATHIC		01/11/2009

Labeler - Izun Pharmaceutical Corporation (624194523)

Establishment
Name	Address	ID/FEI	Business Operations
LC Beauty		338857935	MANUFACTURE(49589-111)