Label: ZEE BURN RELIEF- burn relief 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 May 2, 2022

If you are a consumer or patient please visit this version.

  • Active Ingredients

    Benzalkonium chloride 0.13%

    Lidocaine hydrochloride 2.0%

  • Purposes

    First aid antiseptic

    Anesthetic

  • Uses

    first aid to help prevent infection and relieve pain in minor burns

  • Warnings

    For external use only.

    Do not use

    • in the eyes
    • over large areas of the body
    • longer than 1 week unless directed by a doctor

    Ask a doctor before use if you have a serious burn

    Stop use and ask a doctor if the condition lasts or gets worse

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • shake well before using
    • clean the affected area
    • spray a small amount on the area 1 to 3 times daily
    • may be covered with a sterile bandage. If bandaged, let dry first.
  • Inactive ingredients

    diazolidinyl urea, edetate disodium, glycerin, hydroxypropyl methylcellulose, methylparaben, octoxynol 9, propylparaben, purified water, tea tree oil, trolamine

  • Questions?

    1-800-327-2704 or zeemedical.com

  • NDC Package Code 42961-010-01

    label-42961-010.jpg

    BURN RELIEF SPRAY

    First Aid

    Antiseptic/Anesthetic

    Treats minor burns

    Relieves pain

    Helps prevent infection

    2 fl oz (59 ml)

    ZEE

    Distributed by Zee Medical Distributors, LLC

    Mason, OH 45040

    1805

  • INGREDIENTS AND APPEARANCE
    ZEE BURN RELIEF 
    burn relief spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42961-030
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 100 mL
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS2 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    OCTOXYNOL-9 (UNII: 7JPC6Y25QS)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42961-030-0159 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product04/26/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/26/2022
    Labeler - Cintas Corp (056481716)
    Establishment
    NameAddressID/FEIBusiness Operations
    WaterJel Technologies155522589manufacture(42961-030)