Label: GOOD NEIGHBOR PHARMACY BURN RELIEF ALOE EXTRA- 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 July 17, 2015

If you are a consumer or patient please visit this version.

  • Drug Facts

  • Active ingredient

    Lidocaine 0.50%

  • Purpose

    External analgesic

  • Uses

    Temporarily relieves pain and itching due to: • sunburn • minor

    burns • minor cuts • scrapes • insect bites • minor skin 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 120ºF.

  • Stop use and ask 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.

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

  • 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 into palm of

    hand and gently apply

  • Inactive ingredients

    Aloe Barbadensis Leaf Juice,

    SD Alcohol 40, Propylene Glycol, Glycerin, Simethicone, Tocopheryl

    Acetate, Triethanolamine, Carbomer, Diazolidinyl Urea, Methylparaben,

    Propylparaben, Disodium Cocoamphodipropionate, Disodium EDTA.

  • *This product is not manufactured or distributed by Schering-Plough Healthcare Products, Inc., owner of the Solarcaine® trademark. Distributed By AmerisourceBergen 1300 Morris Drive, Chesterbrook, PA 19087 Visit us at www.goodneighborpharmacy.com

  • Good Neighbor Pharmacy Burn Relief Spray

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  • INGREDIENTS AND APPEARANCE
    GOOD NEIGHBOR PHARMACY BURN RELIEF  ALOE EXTRA
    lidocaine spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:46122-113
    Route of AdministrationCUTANEOUS
    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)  
    SIMETONE (UNII: 387DQL493M)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
    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:46122-113-21127 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34810/28/2011
    Labeler - AmerisourceBergen Drug Corporation (007914906)
    Establishment
    NameAddressID/FEIBusiness Operations
    Product Quest Mfg, LLC927768135manufacture(46122-113) , label(46122-113)