Label: PURISTIC- sodium chlorite liquid

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

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Drug Label Information

Updated April 25, 2020

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  • ACTIVE INGREDIENT

    sodium chlorite

  • INACTIVE INGREDIENT

    water, citric acid

  • PURPOSE

    ■ remove 99.9% of viruses, bacteria & fungi

    ■ deodorizes the immediate area round it

  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of the children

  • INDICATIONS & USAGE

    ■ 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

  • WARNINGS

    For external use only. Flammable. Keep away from heat or flame.

    Do not use

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

    When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse thoroughly with water.

    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    for external use only

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    PURISTIC 
    sodium chlorite liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76648-0001
    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 ACETATE (UNII: DSO12WL7AU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76648-0001-16 mL in 1 SYRINGE, PLASTIC; Type 0: Not a Combination Product04/10/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other04/10/2020
    Labeler - Purgofarm Co Ltd (688484719)
    Registrant - Purgofarm Co Ltd (688484719)
    Establishment
    NameAddressID/FEIBusiness Operations
    Purgofarm Co Ltd688484719manufacture(76648-0001)
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