Label: INSTANT BURN RELIEF ALOE EXTRA CVS- 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 November 30, 2017

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  • Actives

    Lidocaine USP .50%

  • Purpose

    External analgesic

  • Uses

    Temporarily relieves pain and itching due to:

    • sunburn
    • minor burns
    • scrapes
    • insect bites
    • minor irritations

  • Warnings

    For external use only.

    Flammable: Do not use while smoking or near heat or flame

  • Do not use

    in large quantities, particularly over raw surfaces or blistered areas

  • When using this product

    • keep out of eyes
    • use only as directed
    • do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120F
  • Stop use and ask a doctor if

    • conditions gets worse
    • symptoms last more than 7 days
    • symptoms clear up and occur again in a few days
  • Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • shake well
    • adults and children 2 years of age and older: apply to affected area not more than 3-4 times daily
    • children under 2 years of age: ask a doctor
    • to apply to face, spray into palm of hand and gently apply
  • Inactive ingredients

    Aloe Barbadensis Leaf Juice, SD Alcohol 40, Propylene Glycol, Glycerin, Simethicone, Tocopheryl Acetate (Vitamin E Acetate), Triethanolamine, Carbomer, Diazolidinyl Urea, Methylparaben, Propylparaben, Disodium Cocoamphodipropionate, Disodium EDTA.

  • PRINCIPAL DISPLAY PANEL

    CVS

    pharmacy

    ​INSTANT

    BURN RELIEF

    SPRAY

    ALOE EXTRA

    • instant pain relief with Lidocaine
    • Cooling, moisturizing itch relief

    Net WT 4.5 OZ (127g)

    image description

  • INGREDIENTS AND APPEARANCE
    INSTANT BURN RELIEF ALOE EXTRA  CVS
    lidocaine 0.50% spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-230
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE.50 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ALCOHOL (UNII: 3K9958V90M)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    DISODIUM COCOAMPHODIPROPIONATE (UNII: 6K8PRP397M)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59779-230-04127 g in 1 CAN; Type 0: Not a Combination Product11/11/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34811/11/2014
    Labeler - CVS (062312574)
    Registrant - Product Quest Mfg, LLC (927768135)
    Establishment
    NameAddressID/FEIBusiness Operations
    Product Quest Mfg, LLC927768135manufacture(59779-230) , label(59779-230)
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