Label: SOLARCAINE- lidocaine spray

  • NDC Code(s): 11523-0404-1, 11523-0404-2
  • Packager: Bayer HealthCare LLC.
  • 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 May 16, 2017

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Lidocaine 0.5%

  • 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

    When using this product

    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. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.
    • do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120°F.

    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. 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 to 4 times daily
    • children under 2 years of age: ask a doctor
    • to apply to face, spray in palm of hand and gently apply
  • Inactive Ingredients

    aloe barbadensis leaf juice, isobutane, propane, propylene glycol, glycerin, simethicone, tocopheryl acetate (vitamin E acetate), triethanolamine, carbomer, diazolidinyl urea, methylparaben, propylparaben, disodium cocoamphodipropionate, disodium EDTA

  • PRINCIPAL DISPLAY PANEL - 170 g Can Label

    #1

    Sunburn

    Relief


    BRAND

    PAIN RELIEVING SPRAY

    WITH Lidocaine

    Solarcaine®

    Cools Instantly

    Restores Moisture to

    Sunburned Skin

    Doctor Tested • Alcohol Free

    cool aloe

    burn relief

    formula

    NET WT 6 OZ (170g)

    Can label

  • INGREDIENTS AND APPEARANCE
    SOLARCAINE 
    lidocaine spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11523-0404
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE5 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DISODIUM COCOAMPHODIPROPIONATE (UNII: 6K8PRP397M)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ISOBUTANE (UNII: BXR49TP611)  
    PROPANE (UNII: T75W9911L6)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    Product Characteristics
    Colorwhite (Viscous hazy colorless to off-white liquid) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11523-0404-1127 g in 1 CAN; Type 0: Not a Combination Product03/01/2016
    2NDC:11523-0404-2170 g in 1 CAN; Type 0: Not a Combination Product03/01/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34804/06/2012
    Labeler - Bayer HealthCare LLC. (112117283)