Periactive Mouthwash
FDA Label NDC 49589-111

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Izun Pharmaceutical Corporation for the product Periactive (NDC 49589-111). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, otc - purpose, uses, allergy alert, otc - keep out of reach of children, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Other

→ Otc - Purpose

→ Uses

→ Allergy Alert

→ Otc - Keep Out Of Reach Of Children

→ Directions

→ Other Information

→ Inactive Ingredients

→ Questions?

→ Principal Display Panel - 500 Ml Bottle Label

Other

Drug Facts:

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

Otc - Purpose

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

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.

Otc - Keep Out Of Reach Of Children

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 flavor

contains one or more of these ingredients

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