Label: GREENBERRY- benzalkonium 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 9, 2020

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  • Active Ingredient

    Benzalkonium Chloride 0.13%

  • Purpose

    Antimicrobial agent

  • Uses

    Decreases bacteria on skin.

  • Warnings

    For external use only.

    Do not use if you are allergic to any of the ingredients.

    When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water.

    Stop use and ask a doctor if irritation or rash develops and continues for more than 72 hours.

  • 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

    Open lid and remove wipes.
    Wet hands thoroughly with product and let hands air dry.
    Throw used wipe in trash.
    Do not flush.

     Adults and children 2 years and over: Apply to hands. allow hands to dry without wiping.
     Children under 2 years: Ask a doctor before use.

  • Inactive ingredients

    c12-14 Alkyl Dymethyl, Ethylbenzyl Ammonium Chloride, Alkyl Polyglucoside, Disodium EDTA, Propylene glycol, Aqua

  • Package Label - Principal Display Panel

    Label, 10 Wipes

    Label_1

    Label 110 Wipes
    Label_2

  • INGREDIENTS AND APPEARANCE
    GREENBERRY 
    benzalkonium cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77965-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Benzalkonium Chloride (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) Benzalkonium Chloride1.3 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    N-ALKYL ETHYLBENZYL DIMETHYL AMMONIUM (C12-C14) (UNII: 85440928RV)  
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77965-001-0110 in 1 POUCH06/10/2020
    13.8 mL in 1 NOT APPLICABLE; Type 0: Not a Combination Product
    2NDC:77965-001-0272 in 1 CANISTER06/10/2020
    23.8 mL in 1 NOT APPLICABLE; Type 0: Not a Combination Product
    3NDC:77965-001-03110 in 1 POUCH06/10/2020
    33.8 mL in 1 NOT APPLICABLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/10/2020
    Labeler - Greenberry Eco Group LLC (080300128)
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