Label: SOLARCAINE- lidocaine spray

  • NDC Code(s): 11523-0404-1, 11523-0404-2
  • Packager: Bayer HealthCare LLC.
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated October 11, 2023

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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
    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)  
    DISODIUM COCOAMPHODIPROPIONATE (UNII: 6K8PRP397M)  
    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 DrugM01604/06/2012
    Labeler - Bayer HealthCare LLC. (112117283)
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