Label: CLEANSING DISINFECTION WIPES cloth

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated July 11, 2020

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  • Active Ingredient(s)

    Alcohol 10% w/w

    Benzalkonium Chlorid 0. 1%w/w

    Poly( hexamethylenebiguanide )hydro-chloride 0.05%w/w

    Didecyl Dimethylammonium Chloride 0.3%w/w

  • Purpose

    Antiseptic

  • Use

    USE FOR HAND AND SKIN SURFACE DISINFECTING AND CLEANSING

  • Warnings

    For extemal use only. Keep away from sunlight, store in a cool, dry place

  • 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 and sore or broken skin, If contact with eyes occurs, rinse thoroughly with water.top use and ask a doctor if irritation or rash occurs, These may be signs of a serious condition Keep out of reach of children. Get medical help or contact a Poison Control Center right away if needed

  • STOP USE

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

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. Get medical help or contact a Poison Control Center right away if needed

  • Directions

    Open lid, For first time user, remove tamper evident seal, Pullout wipes as needed. Close the lid after use each time top revent moisture loss

  • Other information

    Do not store above 40 °C. May discolor some fabrics and surfaces
    Store between15-30°C

  • Inactive ingredients

    Water

  • Package Label - Principal Display Panel

    810305080100

  • INGREDIENTS AND APPEARANCE
    CLEANSING DISINFECTION WIPES 
    cleansing disinfection wipes cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78293-008
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.1   in 100 
    POLIHEXANIDE (UNII: 322U039GMF) (POLIHEXANIDE - UNII:322U039GMF) POLIHEXANIDE0.05   in 100 
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL10   in 100 
    DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B) (DIDECYLDIMONIUM - UNII:Z7F472XQPA) DIDECYLDIMONIUM CHLORIDE0.3   in 100 
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78293-008-018 in 1 BAG; Type 0: Not a Combination Product07/12/2020
    2NDC:78293-008-0210 in 1 BAG; Type 0: Not a Combination Product07/12/2020
    3NDC:78293-008-0330 in 1 BAG; Type 0: Not a Combination Product07/12/2020
    4NDC:78293-008-0450 in 1 BAG; Type 0: Not a Combination Product07/12/2020
    5NDC:78293-008-0580 in 1 BAG; Type 0: Not a Combination Product07/12/2020
    6NDC:78293-008-06100 in 1 BAG; Type 0: Not a Combination Product07/12/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/12/2020
    Labeler - Guangdong Bolicen Bio-Technology Co., Ltd. (554525110)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guangdong Bolicen Bio-Technology Co., Ltd.554525110manufacture(78293-008)
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