Label: WIPE OUT LAVENDER SCENT ANTIBACTERIAL- benzalkonium chloride spray

  • 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 November 7, 2020

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  • Active Ingredient

    Benzalkonium Chloride 0.13%

    Purpose

    Antibacterial

  • Use

    ■ To decrease bacteria on the skin that could cause disease

  • WARNINGS

    For external use only. Flammable.

    When using this product,

    keep out of eyes. In case of contact with eyes, flush thoroughly with water

    Avoid contact with broken skin

    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

  • Directions

    Hold can upright 6"-8" from hand. 

    Spray 3-4 seconds until covered with mist

    For children under 6, use only under adult supervision

    Not recommended for infants

  • Other Information

    Contents under pressure

    Keep away from heat, sparkles, and open flame

    Do not puncture or incinerate container

    keep in dry, cool and well ventilated place

    Recommended storage temperature: 32F-104F (0-40C)

  • Inactive ingredients

    Aloe Barbadensis Leaf Etract, Fragrance, Glycerin, Phenoxyethanol, Tocopheryl Acetate, Water

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    WIPE OUT LAVENDER SCENT ANTIBACTERIAL 
    benzalkonium chloride spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77878-018
    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
    WATER (UNII: 059QF0KO0R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77878-018-01710 mL in 1 BOTTLE; Type 0: Not a Combination Product11/07/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A11/07/2020
    Labeler - TZUMI INNOVATIONS LLC (117426322)
    Establishment
    NameAddressID/FEIBusiness Operations
    Xiamen Tesimeier Biotechnology Co., Ltd.550462445manufacture(77878-018)
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