Label: DISINFECTANT WET TISSUES- chlorhexidine acetate cloth

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

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Drug Label Information

Updated April 13, 2020

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  • SPL UNCLASSIFIED SECTION

    Disinfectant Wet Tissues

  • Active Ingredient(s)

    Chlorhexidine acetate 0.2g/100mL

    Purpose: Antiseptic

  • Purpose

    Antiseptic

  • Use

    Disinfectant Wet Tissues to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

  • 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

    • Wipe the skin, hands and face for sanitation and disinfection
    • Supervise children under 6 years of age when using this product to avoid swallowing.
  • Other information

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

    Primary Alcobol Ethoxylate
    Medicinal Glycerin
    Ethoxylated lanolin
    Kathon.cmit/mit
    Purity Water

  • Package Label - Principal Display Panel

    15 CLOTH IN 1 PACKAGE NDC: 74974-010-01

    LABEL

  • INGREDIENTS AND APPEARANCE
    DISINFECTANT WET TISSUES 
    chlorhexidine acetate cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74974-010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLORHEXIDINE ACETATE (UNII: 5908ZUF22Y) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE ACETATE0.2 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    C12-15 PARETH-10 (UNII: Z0QJT9586T)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    PEG-10 LANOLIN (UNII: PLH8U521GH)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74974-010-0165 mL in 1 PACKAGE; 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 - Swashes (Shenzhen) Co., Ltd. (421263450)
    Establishment
    NameAddressID/FEIBusiness Operations
    Swashes (Shenzhen) Co., Ltd.421263450manufacture(74974-010)
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