Label: NATURAL SEAL ITCH RELIEF FOR KIDS- 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 November 11, 2020

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  • DRUG FACTS

  • Active Ingredients:

    Lidocaine 1%

  • Purpose:

    Topical anesthetic

  • Uses:

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

  • Warnings:

    For external use only. Avoid contact with eyes. Do not ingest.

    Keep out of reach from children 2 years of age and younger.

  • Directions:

    Shake well then apply firm spray. DO NOT RUB IN. Allow a thin, clear film to set. Barrier is thin, invisible once dry. Apply up to 3× a day for 7 days. Consult a doctor if condition worsens.

  • Inactive Ingredients:

    Purified water, ethanol, acrylates copolymer, cellulose 

  • SPL UNCLASSIFIED SECTION

    FOR KIDS!

    Worry free first aid for kids

    Soothing • Protective • Waterproof Seal

    for Cuts, Scrapes, Rashes, Burns & Insect Bites

    Made by Moms for Moms!

    Questions? Contact us at info@kericure.com or visit www.KeriCure.com

    MADE IN THE USA

    KeriCure® 

    Baltimore, MD 21229

  • Packaging

    IMAGE

  • INGREDIENTS AND APPEARANCE
    NATURAL SEAL ITCH RELIEF FOR KIDS 
    lidocaine spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78280-712
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE10 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:78280-712-1025 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product10/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34810/01/2020
    Labeler - Kericure Inc. (966638681)
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