Label: ADVANCED SEAL BARRIER PLUS PAIN RELIEF- lidocaine 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 27, 2020

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  • DRUG FACTS

  • Active Ingredients:

    Lidocaine 2%

  • Purpose:

    Topical anesthetic

  • INDICATIONS & USAGE

    Uses: For the temporary relief of pain and itch in minor cuts, burns, scrapes, skin irritations, insect bites and sunburn

  • WARNINGS

    Warnings: For external use only. Avoid contact with eyes. Do not ingest. Contact a doctor if pregnant, breastfeeding, or if condition worsens.

    Keep out of reach of children.

  • DOSAGE & ADMINISTRATION

    Directions: Adults & children age 2 & older. Shake well then apply spray. DO NOT RUB IN. Allow a clear, thin film to set. Apply up to 3x a day for 7 days. Children under 2 years of age consult a physician

  • INACTIVE INGREDIENT

    Inactive Ingredients: Purified water, ethanol, polyacrylate polymer, cellulose

  • SPL UNCLASSIFIED SECTION

    Soothe, Seal & ProtectTM

    Lidocaine + breathable, elastic barrier

    Seals in hydration for Advanced Healing

    Cuts • Burns • Rashes • Irritation & More

    KeriCureMedical.com

    KeriCure Inc. Baltimore, MD 21229

  • Packaging

    image description

  • INGREDIENTS AND APPEARANCE
    ADVANCED SEAL BARRIER PLUS PAIN RELIEF 
    lidocaine spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78280-703
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE20 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)  
    HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) (UNII: S38J6RZN16)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78280-703-0125 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product04/10/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34804/10/2020
    Labeler - Kericure Inc. (966638681)
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