Label: ANTIBACTERIAL HAND WIPES (loveit wipes- 0.2% ddac 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 August 17, 2020

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  • Active Ingredient(s)

    Quaternary ammonium salt (DDAC) 0.2%v/v;
    Benzalkonium Chloride 0.1% v/v.

  • Purpose

    Antibacterial;

  • Use

    For adult: Apply wipe to hands. Allow to air dry without wiping.

  • Warnings

    Warning: Avoid contact with eyes or clothing.

    If swallowed, get medical help or contact a poison control center right away.

    Do not flush.

  • Do not use

    Children 2 and under: Ask a doctor before use.

  • WHEN USING

    Avoid contact with eyes.

    For baby items and surfaces that may have contact with food, Please clean with water after applying wipes.

  • STOP USE

    If irritation occurs, Stop use and consult a doctor.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • Directions

    To open: Unscrew lid, remove wipe pouch and dispose of safety sealed bag.

    Return wipes, feed centre wipe through dispenser hole.

    Secure lid.

  • Inactive ingredients

    Pure water 99.5%; Glycerol 0.1%; Ethylhexyl glycerin 0.1%.

  • storage and handling

    Store in a cool dry place away from direct sunlight.

  • Package Label - Principal Display Panel

    100 wipes in 1 Canister;
    NDC: 78183-030-01;

    100u

  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL HAND WIPES 
    loveit wipes (0.2% ddac) cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78183-030
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    QUATERNIUM-18 HECTORITE (UNII: IIS3YBV1XX) (QUATERNIUM-18 HECTORITE - UNII:IIS3YBV1XX) QUATERNIUM-18 HECTORITE0.2 U  in 100 U
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.1 U  in 100 U
    Inactive Ingredients
    Ingredient NameStrength
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) 0.1 U  in 100 U
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX) 0.1 U  in 100 U
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78183-030-01100 U in 1 CANISTER; Type 0: Not a Combination Product08/17/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/17/2020
    Labeler - Kunming Ansheng Industry & Trade Co., Ltd. (421081801)
    Establishment
    NameAddressID/FEIBusiness Operations
    Kunming Ansheng Industry & Trade Co., Ltd.421081801manufacture(78183-030) , label(78183-030)
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