PURISTIC- sodium chlorite liquid 
MEDI K Co., Ltd.

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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82422-001 PURISTIC

Active Ingredients

Sodium chlorite 4.6%

Purpose

Disinfecting Agent

Uses

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

Warning

For external use only

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

When using this product

■ if following abnormal symptoms persist, discontinue use

Do not use

■ 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.

■ 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.

Directions

■ 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

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

Inactive Ingredients

Water, Citric acid

Package Label

82422-001-01

PURISTIC 
sodium chlorite liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82422-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM CHLORITE (UNII: G538EBV4VF) (CHLORITE ION - UNII:Z63H374SB6) SODIUM CHLORITE4.6 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82422-001-016 mL in 1 BOTTLE; Type 0: Not a Combination Product11/27/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other11/27/2021
Labeler - MEDI K Co., Ltd. (695158681)
Registrant - MEDI K Co., Ltd. (695158681)
Establishment
NameAddressID/FEIBusiness Operations
MEDI K Co., Ltd.695158681manufacture(82422-001)

Revised: 11/2021
Document Id: d1bb2aed-302b-6907-e053-2995a90adcde
Set id: d1bb2aed-302a-6907-e053-2995a90adcde
Version: 1
Effective Time: 20211126
 
MEDI K Co., Ltd.