BURN RELIEF SIGNATURE CARE (LIDOCAINE 0.50%) SPRAY [BETTER LIVING]

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BURN RELIEF SIGNATURE CARE (LIDOCAINE 0.50%) SPRAY [BETTER LIVING]
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NDC 21130-761-04
Set ID 399e7f75-4fd6-4515-84f2-f0e24b2984b9
Category HUMAN OTC DRUG LABEL
Packager Better Living
Generic Name
Product Class Amide Local Anesthetic, Antiarrhythmic
Product Number
Application Number PART348
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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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