Active Ingredients
Sodium chlorite 4.6%
Puristic
FDA Label NDC 82422-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Medi K Co., Ltd. for the product Puristic (NDC 82422-001). 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 active ingredients, purpose, uses, warning, when using this product, do not use, otc - ask doctor, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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.
Otc - 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.
Otc - 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
* Please review the disclaimer below.
