Label: DISINFECTANT WET TISSUES- chlorhexidine acetate cloth

  • 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 April 13, 2020

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

  • 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)