Label: PURISTIC- sodium chlorite liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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.

Drug Label Information

Updated November 26, 2021

If you are a consumer or patient please visit this version.

  • 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

    82422-001-01

  • INGREDIENTS AND APPEARANCE
    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)