Label: H2OCEAN NOTHING- benzalkonium cl, lidocaine hcl liquid

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated October 23, 2024

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • Drug Facts

  • Active ingredients

    Benzalkonium Cl 0.13%
    Lidocaine HCl 4%

  • Purpose

    First aid antiseptic
    Pain reliever

  • Uses

    • first aid to help reduce the risk of infection in: • minor cuts • scrapes • burns
    • first aid for the temporary relief of pain and itching associated with: • minor burns • sunburn • minor cuts • scrapes • insect bites • rashes due to poison ivy

  • Warnings

    For external use only.

    Do not use • in the eyes or apply over large areas of the body • longer than 1 week unless directed by a doctor • in large quantities, particularly over raw surfaces or blistered areas

    Ask a doctor before use if you have • deep or puncture wounds • animal bites • serious burns

    Stop use and ask a doctor if • condition worsens • symptoms persist for more than 7 days or clear up and occur again within a few days

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

  • Directions

    • clean the affected area
    • adults and children 2 years of age and older: apply a small amount of this product on the area 1 to 3 times daily 
    • may be covered with a sterile bandage
    • if bandaged, let dry first
    • children under 2 years of age: do not use, consult a physician

  • Other information

    • this package is child-resistant
    • store at room temperature

  • Inactive ingredients

    Aloe (Aloe barbadensis) Leaf Juice, Disodium EDTA, Poloxamer 407, Sea Salt, Water

  • Questions?

    +1-772-219-8183

  • SPL UNCLASSIFIED SECTION

    First In First Aid

    ACTS IN 2 MINUTES

    LASTING UP TO 20 MINUTES

    MAX STRENGTH

    Antiseptic and Anesthetic

    RECYCLABLE

    Distributed By
    H2Ocean, LLC.

    Stuart, FL,
    USA 34997

    Distributed in Europe By
    H2Ocean Europe SARL, LTD.
    Waterford
    Ireland, X91 EH5N

    USA. / EU. +1-772-219-8183

    info@h2ocean.com
    www.h2ocean.com
    Made in USA

  • Packaging

    Nothing-104

  • INGREDIENTS AND APPEARANCE
    H2OCEAN NOTHING 
    benzalkonium cl, lidocaine hcl liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70411-104
    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
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS4 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    SEA SALT (UNII: 87GE52P74G)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70411-104-5050 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product07/15/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00307/15/2024
    Labeler - H2Ocean, LLC (136298069)