Label: ANTIBACTERIAL WIPES- benzalkonium chloride cloth

  • NDC Code(s): 75109-504-01, 75109-504-02, 75109-504-03, 75109-504-04, view more
    75109-504-05, 75109-504-06, 75109-504-07, 75109-504-08, 75109-504-09, 75109-504-10, 75109-504-11, 75109-504-12
  • 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 14, 2022

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

View All Sections
  • Active Ingredient

    Benzalkonium Chloride 0.3%

    Purpose

    Antiseptic

  • USE

    ●For hand sanitizing to decrease bacteria on the skin.
    ●Apply topically to the skin to help prevent cross contamination.
    ●Recommended for repeated use.
    ●Dries in seconds.

  • Warning

    ●For external use only.
    ●Do not use in or contact the eyes.
    " Stop use and ask a doctor if too much skin irritation or
    sensitivity develops or increases.

    ●Keep out of reach of children. If swallowed, get medical
    help or contact a Poison Control Center immediately.

  • Directions

    ●Gently pull back resealable label, remove and use wipe
    as required.
    ， Reseal back after use.

  • Inactive ingredients

    Water, Phenoxyethanol, DMDM Hydantoin, Ethylparaben,
    Methylparaben, Polysorbate 20, Fragrance, Disodium EDTA,
    Sodium Citrate, Cetylpyridinium Chloride.

  • PRINCIPAL DISPLAY PANEL

    1

  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL WIPES 
    benzalkonium chloride cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75109-504
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.3 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
    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)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorLEMONImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75109-504-0150 in 1 BAG06/21/2020
    15.5 g in 1 POUCH; Type 0: Not a Combination Product
    2NDC:75109-504-0210 in 1 PACKAGE06/21/2020
    258 g in 1 POUCH; Type 0: Not a Combination Product
    3NDC:75109-504-0325 in 1 PACKAGE06/21/2020
    3135 g in 1 POUCH; Type 0: Not a Combination Product
    4NDC:75109-504-0450 in 1 PACKAGE06/21/2020
    4270 g in 1 POUCH; Type 0: Not a Combination Product
    5NDC:75109-504-0580 in 1 PACKAGE06/21/2020
    5430 g in 1 POUCH; Type 0: Not a Combination Product
    6NDC:75109-504-06100 in 1 PACKAGE06/21/2020
    6530 g in 1 POUCH; Type 0: Not a Combination Product
    7NDC:75109-504-0770 in 1 CANISTER06/21/2020
    7387.845 g in 1 POUCH; Type 0: Not a Combination Product
    8NDC:75109-504-08100 in 1 CANISTER06/21/2020
    8316.5 g in 1 POUCH; Type 0: Not a Combination Product
    9NDC:75109-504-09300 in 1 CANISTER06/21/2020
    9849.5 g in 1 POUCH; Type 0: Not a Combination Product
    10NDC:75109-504-10800 in 1 BAG06/21/2020
    101543.43 g in 1 POUCH; Type 0: Not a Combination Product
    11NDC:75109-504-111200 in 1 BAG06/21/2020
    112300.15 g in 1 POUCH; Type 0: Not a Combination Product
    12NDC:75109-504-121500 in 1 BAG06/21/2020
    122867.69 g in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/21/2020
    Labeler - Kangna (Zhejiang) Medical Supplies Co., Ltd. (554530173)
    Establishment
    NameAddressID/FEIBusiness Operations
    Kangna (Zhejiang) Medical Supplies Co., Ltd.554530173manufacture(75109-504)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!