Label: ANTIBACTERIAL WIPES LEMON SCENT- benzalkonium chloride swab

  • 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 June 29, 2020

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  • Active Ingredient

    Benzalkonium Chloride 0.3%

    Purpose

    Antiseptic

  • USE

    • For hand sanitizing to decrease bacteria on the skin.
    • Apply topically to the skin to hlep 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 irritaion and sensitivity develops or increases.

    If swallowed, get medical help or contact a Poison Contrl 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

    label image

  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL WIPES LEMON SCENT 
    benzalkonium chloride swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77907-014
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.30 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77907-014-0110 in 1 BAG06/29/2020
    150 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 finalpart333A06/29/2020
    Labeler - Hangzhou Yitong Biotech Co., Ltd. (554532766)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hangzhou Yitong Biotech Co., Ltd.554532766manufacture(77907-014)
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