Label: DISINFECTING WIPES patch

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

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Drug Label Information

Updated November 19, 2020

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  • Active Ingredient(s)

    HCLO (Hypochlorou) 0.5% v/v. Purpose: Antiseptic

  • Purpose

    Antiseptic, Hand Sanitizer

  • Use

    scrub the surface of the skin or the surface of the object for sterilization & disinfention and to remove odor.

  • 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

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

  • STOP USE

    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

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

  • Directions

    Avoid contact with eyes and mouth.

    If allergy occurs,discontinue use and consult with your doctor.

    If a child ingests by accident, get medical advice immediately.

    Please keep it in a cool and dry place

  • Other information

    • Store between 15-30C (59-86F)
    • Avoid freezing and excessive heat above 40C (104F)
  • Inactive ingredients

    water

  • Package Label - Principal Display Panel

    package label

  • INGREDIENTS AND APPEARANCE
    DISINFECTING WIPES 
    disinfecting wipes patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:94973-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYPOCHLOROUS ACID (UNII: 712K4CDC10) (HYPOCHLOROUS ACID - UNII:712K4CDC10) HYPOCHLOROUS ACID0.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:94973-002-0160 in 1 BAG11/20/2020
    14 g in 1 PATCH; Type 0: Not a Combination Product
    2NDC:94973-002-02100 in 1 BAG11/20/2020
    24 g in 1 PATCH; Type 0: Not a Combination Product
    3NDC:94973-002-03150 in 1 BAG11/20/2020
    34 g in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other11/20/2020
    Labeler - Bifone (Pinghu) Medical Equipment Co., Ltd (554550799)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bifone (Pinghu) Medical Equipment Co., Ltd554550799manufacture(94973-002)
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