Label: THE SOLUTION- lidocaine hydrochloride, epinephrine hydrochloride spray

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated September 14, 2023

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  • ACTIVE INGREDIENTS

    LIDOCAINE HCL 5%

    EPINEPHRINE HCL .01%

  • PURPOSE

    LOCAL ANESTHETICS

    VASOCONSTRICTOR

  • USES

    FOR THE TEMPORARY RELIEF OF LOCAL AND ANORECTAL ITCHING, DISCOMFORT, AND PAIN ASSOCIATED WITH ANORECTAL DISORDERS OR ANORECTAL INFLAMMATION.

  • WARNINGS

    • FOR EXTERNAL USE ONLY.
    • AVOID CONTACT WITH THE EYES.
  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN.

  • DO NOT USE THIS PRODUCT IF:

    • PREGNANT OR BREASTFEEDING, ASK A HEALTH PROFESSIONAL BEFOR EUSE.
    • TAMPER EVIDENT "DO NOT USE THIS PRODUCT" IF SAFETY SEAL IS BROKEN OR MISSING.
    • YOU HAVE A HEART CONDITION, HIGH BLOOD PRESSURE, THYROID DISEASE, DIABETES, OR DIFFICULTY IN URINATION DUE TO ENLARGEMENT OF PROSTATE GLAND UNLESS DIRECTED BY A DOCTOR.
  • WHEN USING THIS PRODUCT:

    • DO NOT EXCEED THE RECOMMENDED DAILY USAGE.
    • CERTAIN PERSONS CAN DEVELOP ALLERGIC REACTIONS TO INGREDIENTS IN THIS PRODUCT.
    • DO NOT PUT THIS PRODUCT INTO THE RECTUM BY USING FINGERS OR ANY MEDICAL DEVICE OR APPLICATOR.
    • IF SWALLOWED, CALL YOUR POISON CONTROL CENTER AT 1(800)222-1222.
    • IF CONDITION WORSENS OR DOES NOT IMPROVE WITHIN 7 DAYS, CONSULT A DOCTOR.
  • STOP USE AND ASK A DOCTOR IF:

    • THE SYMPTOM BEING TREATED DOES NOT SUBSIDE, OR REDNESS, IRRITATION, SWELLING, PAIN, OR OTHER SYMPTOMS DEVELOP OR INCREASE.
  • DIRECTIONS

    • CLEAN THE AFFECTED AREA.
    • SENSITIVITY AND POSSIBLE ALLERGY TESTS ADVISED PRIOR TO USE. SPRAY SPARINGLY TO AFFECTED AREA AFTER THOROUGHLY CLEANSING. WAIT UNTIL ANESTHETIC EFFECT OCCURS. YOU MAY REAPPLY TO CONTINUE NUMBING AFFECT.
    • APPLY TO THE AFFECTED AREA UP TO 4 TIMES DAILY.
    • CHILDREN UNDER 12 YEARS OF AGE, CONSULT A DOCTOR.
  • OTHER INFORMATION

    • STORE IN COOL DARK PLACE OR REFRIGERATE.
    • KEEP AWAY FROM DIRECT SUNLIGHT OR HEAT.
    • DISCARD AFTER EXPIRATION DATE.
  • INACTIVE INGREDIENTS

    ALLANTOIN, CAPRYLHYDOXAMIC ACID, ETHOXYDIGLYCOL, 1,2-HEXANEDIOL, PROPANEDIOL, WATER

  • QUESTIONS?

    CALL - 1 (403) 901-8244

  • PRINCIPAL DISPLAY PANEL

    01b LBL_The Solution Art Work_4oz

  • INGREDIENTS AND APPEARANCE
    THE SOLUTION 
    lidocaine hydrochloride, epinephrine hydrochloride spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82617-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS5 g  in 100 mL
    EPINEPHRINE HYDROCHLORIDE (UNII: WBB047OO38) (EPINEPHRINE - UNII:YKH834O4BH) EPINEPHRINE HYDROCHLORIDE0.01 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
    DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
    WATER (UNII: 059QF0KO0R)  
    ALLANTOIN (UNII: 344S277G0Z)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82617-101-14118 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product04/01/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01504/01/2022
    Labeler - SCALP TECH INC (200711913)
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