Label: ANTIBACTERIAL ECO WIPES- benzalkonium chloride cloth

  • NDC Code(s): 75109-522-04, 75109-522-05, 75109-522-06
  • Packager: Kangna (Zhejiang) Medical Supplies Co., Ltd.
  • 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 January 12, 2023

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  • Active Ingredient

    Benzalkonium Chloride 0.13%

    Purpose

    Antiseptic

  • USE

    ●For hand sanitizing to decrease bacteria on the skin.
    ●Apply topically to the skin to help prevent cross contamination.
    ●Not recommended for repeated use.
    ●Dries in seconds.

  • Warning

    For external use only.
    When using this product keep out of eyes, ears, and mouth. In case of eye contact, flush thoroughly with water.
    Stop use 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 a Posion Control Center right away.

  • Directions

    Gently pull back resealable label, remove and use wipes as required.
    Reseal back after use to retain moisture.

  • Inactive ingredients

    Water, Phenoxyethanol, DMDM Hydantoin, Ethylparaben, Methylparaben, Polysorbate 20, Fragrance,
    Disodium EDTA, Sodium Citrate, Aloe Barbadensis Leaf Juice.

  • PRINCIPAL DISPLAY PANEL

    12

  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL ECO WIPES 
    benzalkonium chloride cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75109-522
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75109-522-0410 in 1 BAG03/09/2021
    149 g in 1 PACKAGE; Type 0: Not a Combination Product
    2NDC:75109-522-0550 in 1 BAG03/09/2021
    2236 g in 1 PACKAGE; Type 0: Not a Combination Product
    3NDC:75109-522-0675 in 1 BAG03/09/2021
    3408 g in 1 PACKAGE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/09/2021
    Labeler - Kangna (Zhejiang) Medical Supplies Co., Ltd. (554530173)
    Establishment
    NameAddressID/FEIBusiness Operations
    Kangna (Zhejiang) Medical Supplies Co., Ltd.554530173manufacture(75109-522)
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