PURISTIC- sodium chlorite liquid

PURISTIC by

Drug Labeling and Warnings

PURISTIC by is a Otc medication manufactured, distributed, or labeled by MEDI K Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

• 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.

ASK DOCTOR

■ 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.

KEEP OUT OF REACH OF CHILDREN

• in children less than 2 months of age

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

INGREDIENTS AND APPEARANCE

PURISTIC 
sodium chlorite liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82422-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM CHLORITE (UNII: G538EBV4VF) (CHLORITE ION - UNII:Z63H374SB6)	SODIUM CHLORITE	4.6 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82422-001-01	6 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/27/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		11/27/2021

Labeler - MEDI K Co., Ltd. (695158681)

Registrant - MEDI K Co., Ltd. (695158681)

Establishment
Name	Address	ID/FEI	Business Operations
MEDI K Co., Ltd.		695158681	manufacture(82422-001)