Label: SOLARCAINE BURN PAIN RELIEF 4OZ- solarcaine burn pain relief 4oz spray

  • NDC Code(s): 65197-502-04
  • Packager: WellSpring Pharmaceutical Corporation
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated June 8, 2023

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  • Active Ingredients (w/w)

    Lidocaine HCl 4%

  • 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. 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. Avoid prolonged storage above 40°C (104°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: do not use, ask a doctor
    • to apply to face, spray in palm of hand and gently apply
  • Inactive ingredients

    purified water, propylene glycol, aloe barbadensis leaf juice, polysorbate 80, ethylhexylglycerin, tocopheryl acetate (vitamin E acetate), 2-phenoxyethanol, sodium hydroxide

  • Questions?

    1-844-241-5454  

  • Distributed by:

    Distributed by:

    WellSpring Pharmaceutical Corporation
    Sarasota, FL 34243

    © 2023 WellSpring Pharmaceutical Corporation
    MONEY BACK GUARANTEE

    Solarcaine is FSA/HSA eligible

  • PACKAGE LABEL. PRINCIPAL DISPLAY PANEL

    #1 Pharmacist Recommended*

    * Pharmacy Times/* U.S News & World

    Report 2023-2024

    DOT 2Q M5706

    L50200A | B6522

    CONTAINS NO CFCs WHICH
    DEPLETE THE OZONE LAYER

    Can Artwork Solarcaine 4%

    Solarcaine 4%

  • INGREDIENTS AND APPEARANCE
    SOLARCAINE BURN PAIN RELIEF 4OZ 
    solarcaine burn pain relief 4oz spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65197-502
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS4 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    POLYSORBATE 81 (UNII: 2MSF640LWM)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65197-502-04113 g in 1 CAN; Type 0: Not a Combination Product01/01/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01701/01/2024
    Labeler - WellSpring Pharmaceutical Corporation (110999054)
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