NOTHING (LIDOCAINE) LIQUID [H2OCEAN, LLC]

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NOTHING (LIDOCAINE) LIQUID [H2OCEAN, LLC]
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NDC 70411-102-50
Set ID ce3ffebf-e3c0-47c2-b8cf-ecce4ef8c51d
Category HUMAN OTC DRUG LABEL
Packager H2Ocean, LLC
Generic Name
Product Class Amide Local Anesthetic, Antiarrhythmic
Product Number
Application Number PART348
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  • Active Ingredient

    Lidocane hydrochloride, 4%

  • Purpose

    Pain reliever

  • Uses

    For the temporary relief of pain and/or itching associated with minor skin irritations

  • Warnings

    For external use only

    When using this product avoid contact with the eyes.  In case of eye contact, flush eyes with water.

    Do not use in large quantities, particularly on raw surfaces of blistered areas.

    If condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use and consult a doctor.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.  If swallowed, get medical help or contact a poison control center immediately.

  • Directions

    Adults and children 2 years of age and older:  Apply 1-2 pumps of the foam soap to the affected area 3-4 times daily.

    Children under 2 years of age: consult a doctor.

    For best results, do not use with alcohol based products.

  • Inactive Ingredients

    Purified water, Poloxamer, Aloe Barbadensis Leaf Juice, Benzalkonium Chloride, Disodium ETDA, Sea Salt

  • SPL UNCLASSIFIED SECTION

    Questions? 1-888-420-2326

  • SPL UNCLASSIFIED SECTION

    H2Ocean (r)

    First In First Aid (TM)

    H2Ocean's Nothing is the choice for first aid when ou want to feel NOTHING.

    H2Ocean, LLC, Stuart, FL, USA

    H2Ocean Europe SRL LTD., Waterford, Ireland

    USA / EU +1 772.219.8183

    Info@H2Ocean.com

    Made in USA

    www.H2Ocean.com

  • PRINCIPAL DISPLAY PANEL

    H2Ocean(r)

    First In First Aid (TM)

    NOTHING (TM)

    Pain Relieving Soap with Lidocaine

    Anesthetic

    1.7 Fl. Oz. (50 ml.)

    20180130 102 H2Ocean Nothing

  • INGREDIENTS AND APPEARANCE
    NOTHING 
    lidocaine liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70411-102
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE4 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    POLOXAMER 124 (UNII: 1S66E28KXA)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    DISODIUM ETHYLENEDIAMINEDIACETATE (UNII: EQL53S5L0F)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70411-102-5050 mL in 1 BOTTLE; Type 0: Not a Combination Product02/07/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34802/07/2018
    Labeler - H2Ocean, LLC (136298069)
    Establishment
    NameAddressID/FEIBusiness Operations
    Products by O2, Inc.136932444manufacture(70411-102)
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