Label: SANITIZING 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 January 6, 2021

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  • Active Ingredient(s)

    benzalkonium chloride 0.13%

  • Purpose

    Antimicrobial

  • Inactive ingredients

    Aqua,Isopropyl alcohol, Propylene glycol, Tocopherol acetate, polysorbote 20, phenoxyethanol, Perfume

  • Uses

    Suitable for skin cleaning and sterilization

  • Warnings

    For external use only.

    Flammable,keep away from fire or flame

  • Do not use

    • on open skin wounds
  • WHEN USING

    When using this product, avoid contact with eyes.In case of contact with eyes, rinse with water to remove.

  • STOP USE

    Stop use and ask a doctor if irritation or redness develop.

  • KEEP OUT OF REACH OF CHILDREN

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

  • Directions

    • Wet hands thoroughly with product and allow to dry without wiping
  • Other information

    • Do not store above 110F
    • May discolor some fabrics
  • Package Label - Principal Display Panel

    160PCS NDC 80991-003-04 003-04

  • INGREDIENTS AND APPEARANCE
    SANITIZING WIPES 
    benzalkonium chloride cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80991-003
    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
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    WATER (UNII: 059QF0KO0R)  
    FAGRAEA BERTEROANA FLOWER OIL (UNII: 6665W245VP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80991-003-04160 in 1 CANISTER11/09/2020
    15 g in 1 APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A11/03/2020
    Labeler - Zhejiang Fanjia Medical Equipment Co., Ltd. (554552225)
    Registrant - Zhejiang Fanjia Medical Equipment Co., Ltd. (554552225)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zhejiang Fanjia Medical Equipment Co., Ltd.554552225manufacture(80991-003) , label(80991-003)
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