Label: ANTIBACTERIAL WIPES- benzalkonium chloride 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 August 6, 2020

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  • ACTIVE INGREDIENT

    Benzalkonium Chloride, 0.11875%

    Cereals Extraction Extract, 0.05%

    2-Phenoxyethanol, 0.02025%

    2-Methy-4-isothiazolin-3-one, 0.00625%

    Iodopropynyl Butylcarbamate, 0.00225%

  • Purpose

    Antibacterial

  • WARNINGS

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

  • Do not use

    On children less than 2 years of age, or on open skin wounds.

  • STOP USING AND ASK 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 Poison Control Center right away.

  • Use

    Sanitizing Wipe helps to reduce bacteria & virus that can potentially cause disease.

    For use when soap & water are not available.

  • DIRECTIONS

    Store in a cool and dry place.

    Romove cover.

    Pull up wipe corner from center of roll.

    Thread through hole in the cover.

    Replace cover.

    Open center cap on cover to remove wipe.

    When not using, close center cap securely to prevent moisture loss.

    Reseal and let hands dry.

    No need to rinse.

  • CAUTION

    WARNING FLAMMABLE

    Keep away from heat, spark, electrical, fire or flame.

  • STORAGE AND HANDLING

    Store in a cool and dry place.

  • INACTIVE INGREDIENT

    1,2-Propanediol

    Water

  • Package label. Principal display panel

    Pa80

  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL WIPES 
    benzalkonium chloride cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78356-211
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE5 mg
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) (METHYLISOTHIAZOLINONE - UNII:229D0E1QFA) METHYLISOTHIAZOLINONE0.2625 mg
    BARLEY (UNII: 5PWM7YLI7R) (BARLEY - UNII:5PWM7YLI7R) BARLEY2.1 mg
    PHENOXYETHANOL (UNII: HIE492ZZ3T) (PHENOXYETHANOL - UNII:HIE492ZZ3T) PHENOXYETHANOL0.84 mg
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB) (IODOPROPYNYL BUTYLCARBAMATE - UNII:603P14DHEB) IODOPROPYNYL BUTYLCARBAMATE0.0945 mg
    Inactive Ingredients
    Ingredient NameStrength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78356-211-2180 in 1 PAIL; Type 0: Not a Combination Product08/06/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/06/2020
    Labeler - Zhejiang Yiwu Anrou Sanitation Article Co., Ltd (547950139)
    Registrant - A03 Lab of BTS (548009541)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zhejiang Yiwu Anrou Sanitation Article Co., Ltd547950139manufacture(78356-211) , label(78356-211)
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