PURISTIC

Manufacturer
MEDI K Co., Ltd.
Effective date
2021-11-26
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:45:08

Label at a glance#

ProductPURISTIC
Active ingredientSODIUM CHLORITE
Label structure12 sections

Indications and uses

■ remove 99.9% of viruses, bacteria & fungi ■ Deodorizes the immediate area round it

Dosage and administration

■ tap lightly downward, gently bend the dot of ampoule ■ content turn yellow, to activate and emit through the body surface ■ content turn white, to be discarded in regular trash

Storage and handling

- read the directions and warnings before use - avoid freezing and excessive heat above 40 degree C (104 degree F)

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Sodium chlorite 4.6%

Purpose

OTC - PURPOSE SECTION

Disinfecting Agent

Uses

DOSAGE & ADMINISTRATION SECTION

■ remove 99.9% of viruses, bacteria & fungi
■ Deodorizes the immediate area round it

Warning

WARNINGS SECTION

For external use only

■ If swallowed, get medical help or contact a Poison Control Center right away.

When using this product

OTC - WHEN USING SECTION

■ if following abnormal symptoms persist, discontinue use

Do not use

OTC - DO NOT USE SECTION

  • in children less than 2 months of age
  • on open skin wounds

■ Do not use the product for a long time in the same area as swelling, inflammation or sickness
may occur due to absorption through the skin.
It is not recommended to use this one area that have been medically treated with a cast or
bandage.
■ Do not use in combination with soap or antibacterial cleansing agents.

OTC - ASK DOCTOR SECTION

■ Stop immediately and consult a doctor if you experience
1) Hypersensitivity symptoms such as erythema, itching and dermatitis.
2) Skin Irritation
3) Following Instructions when using medication
(1) For external use only (Do not use internally)
(2) Avoid getting into the eyes (if contact occurs, wash well with clean water)
■ Be careful not to inhale or use excessively for a long time (ingesting ethanol repeatedly causes irritation to mucous membranes and headaches or other symptoms may appear. When used repeatedly in the same area, skin irritation may occur.
■ Do not use the product for a long time in the same area as swelling, inflammation or sickness may occur due to absorption through the skin.

It is not recommended to use this one area that have been medically treated with a cast or
bandage.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • in children less than 2 months of age

Directions

INDICATIONS & USAGE SECTION

■ tap lightly downward, gently bend the dot of ampoule
■ content turn yellow, to activate and emit through the body surface
■ content turn white, to be discarded in regular trash

Other information

STORAGE AND HANDLING SECTION

- read the directions and warnings before use
- avoid freezing and excessive heat above 40 degree C (104 degree F)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Citric acid

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

82422-001-0182422-001-01

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
82422-001-012023-01-30C16284748780-1f386c649-bdfa-0266-e053-dadaa90a7c1a82422-001 PURISTIC

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82422-001-01PURISTIC6 mL in 1 BOTTLELIQUID61

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82422-001PURISTIC (SODIUM CHLORITE) LIQUID [MEDI K CO., LTD.]1Legacy NDC, 1 package rows20211128_d1bb2aed-302a-6907-e053-2995a90adcde.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82422-00182422-001-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
d1bb2aed-302b-6907-e053-2995a90adcded1bb2aed-302a-6907-e053-2995a90adcde2021-11-26WarningsExact identifier
spl id: d1bb2aed-302b-6907-e053-2995a90adcde
spl set id: d1bb2aed-302a-6907-e053-2995a90adcde

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.