Label: BURN RELIEF- lidocaine spray

  • Category: HUMAN OTC DRUG LABEL

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 July 16, 2019

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  • Active Ingredient

    Lidocaine 0.5%

  • Purpose

    External analgesic

  • Use

    INDICATIONS & USAGE SECTION

    Temporarily relieves pain and itching due to:

    • Sunburn • Minor burns

    • Minor cuts • Scrapes

    • Insect bites • Minor skin irritations

    Dosage & Administration

    For the temporary relief of itching associated with minor skin irritations and rashes due to eczema, insect bites, and poison oak.

  • Warnings

    For external use only.

  • Do not use

    Do not use in large quantities, particularly over raw surfaces or

    blistered areas.

  • When using this product:

    When using this product:
    • Keep out of eyes.
    • Use only as directed.
    • Do not puncture or incinerate. Contents under pressure. Do
    not store at temperature above 120°F.

  • Stop use and ask a doctor if:

    Stop use and ask a doctor if:

    • Condition gets worse

    • Symptoms last more than 7 days

    • Symptoms clear up and occur again in a few days

  • Keep out of reach of children.

    Keep out of reach of children. If swallowed, get medical help or

    contact Poison Control Center right away.

  • Directions

    • Shake well

    • Adults and children 2 years of age and older: apply to

    affected area not more than 3 to 4 times daily

    • Children under 2 years of age: ask a doctor

    • To apply to face, spray on palm of hand and gently apply

  • Inactive Ingredients

    Water, Glycerin, Propanediol, Aloe Barbadensis Leaf Juice,

    Carbomer, Tocopheryl Acetate, PEG-40 Hydrogenated Castor Oil,

    Sodium Lauroyl Sarcosinate, Disodium EDTA, Phenoxyethanol,

    Sodium Hydroxide

  • Questions or comments?

    Distributed by:

    Geiss, Destin & Dunn, Inc.

    Peachtree City, GA 30269

    www.valuelabels.com

    800-715-3485

  • Principal Display Panel

    GoodSense

    Burn Relief

    Continuous Spray

    Topical Analgesic

    With LidocainepROVIDES FAST RELIEF FROM:

    • Sunburn
    • Cuts & scrapes
    • Insect bites,
    • Minor burn & sunburn

    Compare and Save 100% Satisfaction Guaranteed

    NET WT 6 OZ (170 g)

    GoodSense Burn Relief Spray_Label_040319.jpg

  • INGREDIENTS AND APPEARANCE
    BURN RELIEF 
    lidocaine spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70281-640
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE0.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)  
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70281-640-06170 g in 1 CAN; Type 0: Not a Combination Product04/03/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34804/03/2019
    Labeler - Solskyn Personal Care LLC (080010329)
    Establishment
    NameAddressID/FEIBusiness Operations
    KIK Piedmont LLC078482780manufacture(70281-640)
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