Label: DISINFECTING WIPES- hand sanitizer 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 July 30, 2020

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  • Active Ingredient(s)

    Benzalkonium chloride 0.2% w/w. Purpose: Antiseptic

  • Purpose

    Antiseptic, Hand Sanitizer

  • Use

    Disinfecting Wipes help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

  • Warnings

    For external use only.

  • Do not use

    • in children less than 2 months of age
    • on open skin wounds
  • WHEN USING

    When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

    Stop use and ask a 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 Poison Control Center right away.

  • STOP USE

    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

  • KEEP OUT OF REACH OF CHILDREN

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

  • Directions

    • Wipe surface thoroughly with product and let dry. Discard wipe in trash properly.
    • Supervise children under 6 years of age when using this product to avoid swallowing.
  • Other information

  • Inactive ingredients

    Aloe Barbadensis Leaf Juice, Citric Acid, Didecyl Dimethyl Ammonium Chloride, Glycerin, Vitamin E, Water.

  • Package Label - Principal Display Panel

    80 WIPES in 1 PIAL NDC: 92763-004-01 Package Label

  • Package Label - Principal Display Panel

    800 WIPES in 1 BAG NDC: 92763-004-02 Package Label

  • INGREDIENTS AND APPEARANCE
    DISINFECTING WIPES 
    hand sanitizer cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:92763-004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    TOCOPHEROL (UNII: R0ZB2556P8) 0.0025 g  in 100 g
    DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B) 0.16 g  in 100 g
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) 0.01 g  in 100 g
    GLYCERIN (UNII: PDC6A3C0OX) 0.1 g  in 100 g
    ALOE (UNII: V5VD430YW9) 0.0025 g  in 100 g
    WATER (UNII: 059QF0KO0R) 99.525 g  in 100 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:92763-004-01432 g in 1 PAIL; Type 0: Not a Combination Product07/30/2020
    2NDC:92763-004-024320 g in 1 BAG; Type 0: Not a Combination Product07/30/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/30/2020
    Labeler - Nanofixit Ventures Inc. (723428496)
    Registrant - Nanofixit Ventures Inc. (723428496)
    Establishment
    NameAddressID/FEIBusiness Operations
    Xiamen Ekem Tech.co.,ltd.416208686manufacture(92763-004)
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