Label: DFENZE HOCL SANITIZER AND DISINFECTANT liquid

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

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Drug Label Information

Updated July 21, 2020

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  • Active Ingredient(s)

    HOCL (Hypochlorous Acid) 0.015%

  • Purpose

    Multi Purpose

  • Warnings

    For external use only.

  • Do not use

    • Do not adulterate or dilute. Keep away from direct sunlight and heat. Do not freeze.
  • WHEN USING

    For children 6 years and below, use with supervision. In case of eye contact or skin irritation, flush thoroughly with water and seek medical advice. If pregnant or breast-feeding, consult with your physician prior to use.

  • STOP USE

    /

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • Directions

    1. Turn the spray cap ON
    2. Shake lightly and spray with 20cm distance for 3-5 times from the object
    3. Dry the object well after spraying
    4. Clean the application site if required.
    5. Turn the spray cap OFF after use. Repeat as needed throughout the day. Use it for your daily regimen. No rinsing required.

  • Other information

    Store below 300C, non flammable.

  • Inactive ingredients

    Electrolysed Purified Water & NaCl (Sodium Chloride).

  • INDICATIONS & USAGE

    1. Turn the spray cap ON
    2. Shake lightly and spray with 20cm distance for 3-5 times from the object
    3. Dry the object well after spraying
    4. Clean the application site if required.
    5. Turn the spray cap OFF after use. Repeat as needed throughout the day. Use it for your daily regimen. No rinsing required.

  • Package Label - Principal Display Panel

    3050001000050200001005002000

  • INGREDIENTS AND APPEARANCE
    DFENZE HOCL SANITIZER AND DISINFECTANT 
    dfenze hocl sanitizer and disinfectant liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79762-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYPOCHLOROUS ACID (UNII: 712K4CDC10) (HYPOCHLOROUS ACID - UNII:712K4CDC10) HYPOCHLOROUS ACID0.015 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79762-001-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    2NDC:79762-001-0250 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    3NDC:79762-001-03100 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    4NDC:79762-001-04500 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    5NDC:79762-001-052000 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    6NDC:79762-001-065000 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    7NDC:79762-001-0710000 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    8NDC:79762-001-0820000 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other03/30/2020
    Labeler - JL WATER ENGINEERING SDN. BHD. (659306681)
    Establishment
    NameAddressID/FEIBusiness Operations
    JL WATER ENGINEERING SDN. BHD.659306681manufacture(79762-001)
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