Label: DAILY CARE ANTIBACTERIAL WET HAND- 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 June 27, 2020

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  • DRUG FACTS

  • ACTIVE INGREDIENT

    Benzalkonium chloride 0.115%

    PURPOSE

    Antiseptic

  • USE:

    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 

    do not get into 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.

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

  • DIRECTIONS:

    Adults and children over 2 years of age: apply to hands, allow to dry without wiping. Children under 2 years of age: ask doctor before use. 

  • INACTIVE INGREDIENTS:

    Propylene Glycol,Ethylenediaminetetraacetic acid tetrasodium salt, Sorbitol,Aloe Extract,Glycerine, Purified Water,Fragrance.

  • Package Labeling:

    123

  • INGREDIENTS AND APPEARANCE
    DAILY CARE ANTIBACTERIAL WET HAND 
    benzalkonium chloride cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78107-000
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.15 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SORBITOL (UNII: 506T60A25R)  
    ALOE (UNII: V5VD430YW9)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78107-000-0440 in 1 BAG06/27/2020
    10.115 g in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E06/27/2020
    Labeler - 1 Source Trading LLC (117475928)
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