H2OCEAN NOTHING TATTOO GLIDE AND SOOTHING BALM (LIDOCAINE) OINTMENT [AIDANCE SKINCARE & TOPICAL SOLUTIONS, LLC]

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H2OCEAN NOTHING TATTOO GLIDE AND SOOTHING BALM (LIDOCAINE) OINTMENT [AIDANCE SKINCARE & TOPICAL SOLUTIONS, LLC]
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NDC 24909-901-20
Set ID b5b85ea7-2308-4934-a222-8e1dcbff62bb
Category HUMAN OTC DRUG LABEL
Packager Aidance Skincare & Topical Solutions, LLC
Generic Name
Product Class Amide Local Anesthetic, Antiarrhythmic
Product Number
Application Number PART348
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  • Active Ingredients

    Lidocaine HCL 4%

  • Purpose

    Lidocaine HCL - Topical Anesthetic

  • Uses

    Temporarily relieves pain and itching associated with minor burns, minor cuts or skin irritations

  • Warnings

    For external use only. Stop use and ask a doctor if condition worsens or if symptoms persist for more than 7 days, or clear up and occur again within a few days. When using this product avoid contact with eyes. Flush with water if contact occurs. Do not apply over large areas of the body, particularly over raw surfaces or blistered areas.

    Keep out of reach of children.

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

  • Directions

    Adults and children 2 years and older: Apply externally to the affected area up to 3 to 4 times a day. Children under 2 years: Consult a doctor.

  • Inactive Ingredients

    beeswax (organic), bentonite (volcanic clay), chamomile oil, cotton seed oil, glycerine (vegetable), jojoba seed oil (golden), magnesium oxide, purified water, sea salt, silver oxide, zinc oxide.

  • PRINCIPAL DISPLAY PANEL - 200g Label

    H2Ocean®  First in First Aid™

    NOTHING
    TATTOO GLIDE AND SOOTHING BALM
    Pain Relieving Glide with 4% Lidocaine
    topical anesthetic
    Net WT 200 grams

    Jar Label

  • INGREDIENTS AND APPEARANCE
    H2OCEAN NOTHING TATTOO GLIDE AND SOOTHING BALM 
    lidocaine ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24909-901
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE4 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    BENTONITE (UNII: A3N5ZCN45C)  
    CHAMOMILE FLOWER OIL (UNII: 60F80Z61A9)  
    COTTONSEED OIL (UNII: H3E878020N)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    JOJOBA OIL (UNII: 724GKU717M)  
    MAGNESIUM OXIDE (UNII: 3A3U0GI71G)  
    SEA SALT (UNII: 87GE52P74G)  
    SILVER OXIDE (UNII: 897WUN6G6T)  
    WATER (UNII: 059QF0KO0R)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24909-901-20200 g in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34806/29/2015
    Labeler - Aidance Skincare & Topical Solutions, LLC (018950611)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aidance Skincare & Topical Solutions, LLC018950611manufacture(24909-901) , label(24909-901)
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