Label: BURN RELIEF SIGNATURE CARE- lidocaine 0.50% 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 January 19, 2018

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  • ACTIVE INGREDIENT

    Active ingredient                                                           Purpose
    Lidocaine 0.5%.............................................................Topical anesthetic

  • PURPOSE

  • INDICATIONS & USAGE

    Uses
    For temporary relief of pain associated with pain or itching due to : minor burns, sunburns, minor cuts, insect bites, skin irritation

  • WARNINGS

    Warnings
    For external use only.

    Flammable: Do not use while smoking or near heat or flame
    When using this product • use only as directed • avoid contact with eyes

    Do not puncture or incenerate. Contents under pressure. Do not store at temperature above 120F
    Stop use and ask a doctor if • condition worsens • symptoms persist for more than 7 days or clear up and occur again within
    a few days.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately

  • DOSAGE & ADMINISTRATION

    Directions
    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: consult a doctor.

  • Inactive ingredients

    Aloe Barbadensis Leaf Extract
    Carbomer
    Diazolidinyl Urea
    Disodium Cocoamphodipropionate
    Disodium EDTA
    Glycerin
    Methylparaben
    Propylene Glycol
    Propylparaben
    SD Alcohol 40
    Simethicone
    Tocopheryl Acetate
    Triethanolamine

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    BURN RELIEF  SIGNATURE CARE
    lidocaine 0.50% spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21130-761
    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
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Diazolidinyl Urea (UNII: H5RIZ3MPW4)  
    Disodium Cocoamphodipropionate (UNII: 6K8PRP397M)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    Glycerin (UNII: PDC6A3C0OX)  
    Methylparaben (UNII: A2I8C7HI9T)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Propylparaben (UNII: Z8IX2SC1OH)  
    Alcohol (UNII: 3K9958V90M)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:21130-761-04127 g in 1 CAN; Type 0: Not a Combination Product03/30/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34803/30/2018
    Labeler - Better Living (009137209)
    Registrant - Product Quest Mfg (927768135)
    Establishment
    NameAddressID/FEIBusiness Operations
    Product Quest Mfg927768135manufacture(21130-761) , label(21130-761)
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