Label: ANTIBACTERIAL WIPES 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 June 15, 2020

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  • Active Ingredient(s)

    Benzalkonium chloride 0.13%

  • Purpose

    Antiseptic

  • Use

    Antiseptic.
    For handwashing to decrease bacteria on the skin
    Apply topically to the skin to help prevent cross-contamination
    Recommended for repeated use.
    Dries in seconds
    Not to be used on therapeutic devices and hospital.

  • Warnings

    For extemal use only
    Do not use in or contact the eyes
    Discontinue useif irritation and redness develop. if condition persists for more than 72 hours consult a physician.
    keep out of reach of children unless under adult supervision.
    lf swallowed. get medical help or contact a Poison Control Center immediately.

  • Do not use

    Do not use in or contact the eyes
    Discontinue useif irritation and redness develop. if condition persists for more than 72 hours consult a physician.

  • WHEN USING

    Pull through about one inch. Replace cover Pull out wipes as needed and snap off at a 90° angle. Keep cap closed to prevent evaporation
    Wipe hands, fingers, interdigital areas and wrists thoroughly with towelette. Be sure to utilize the entire wipe surface, Allow to dry
    lf hands are visibly soiled or contaminated use first wipe to clean hands then discard wipe Sanitize with a second wipe discard after single use.

  • STOP USE

    /

  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of children unless under adult supervision.
    lf swallowed. get medical help or contact a Poison Control Center immediately.

  • Directions

    To start feed: Remove cover and discard seal from container. From center of toweled roll, pull up wipe corner, tear off first wipe for use. Twist next wipe into a point and thread through the hole in the container cover.

  • Other information

    Lot No. and Expiration Date can be found on canister.

  • Inactive ingredients

    Bronco
    Ethylhexylglycerin
    Didecyldimonium Chloride
    Propylene Glycol
    Glycerin
    water

  • PRINCIPAL DISPLAY PANEL

    1

  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL WIPES 
    antibacterial wipes cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76991-007
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    STEPRONIN (UNII: 0NOY894QRB)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76991-007-012880 mL in 1 BAG; Type 0: Not a Combination Product05/15/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/30/2020
    Labeler - Hefei Wenqi Industrial & Trade Co., Ltd (530739868)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hefei Wenqi Industrial & Trade Co., Ltd530739868manufacture(76991-007)
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