Label: CURIST LIDOCAINE CAN- lidocaine spray aerosol, spray

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 10, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active Ingredient

    Lidocaine 5%

  • PURPOSE

    Purpose

    Anorectal (hemorrhoidal) spray

  • INDICATIONS & USAGE

    Uses

    • helps relieve the local itching and discomfort associated with inflamed hemorrhoidal tissues
    • temporarily relieves pain and burning
  • WARNINGS

    Warnings

    For external use only

    Flammable - Keep away from fire or flame

    When using this product

    • avoid contact with eyes
    • do not exceed recommended dosage unless directed by doctor
    • do not put this product into the rectum by using fingers or any mechanical device or applicator

    Stop use and ask a doctor if

    • rectal bleeding occurs
    • condition worsens or does not improve within 7 days
    • allergic reaction occurs to ingredients in this product
    • symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase

    If pregnant or breastfeeding, ask a health professional before use

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

  • DOSAGE & ADMINISTRATION

    Directions

    • Adults
      • When practical, cleanse the affected area with mild soap and warm water and rinse throughly
      • Gently dry by patting or blotting with toilet tissue or a soft cloth before application of product.
      • Spray on affected area up to 6 times daily
      • Wash hands after application
      • Children under 12 years of age: consult a doctor.
  • STORAGE AND HANDLING

    Other information

    Store at 15°-30° C (59°-86° F)

  • INACTIVE INGREDIENT

    Inactive ingredients

    alcohol denat., aloe barbadensis leaf extract, carbomer, chamomilla recutita (matricaria) flower extract, cucumis sativus (cucumber) fruit extract, disodium cocoamphodipropionate, disodium EDTA, glycerin, propylene glycol, tocopheryl acetate, triethanolamine, water

  • QUESTIONS

    Questions

    Call 1-844-243-1241 or email hi@curistrelief.com

  • SPL UNCLASSIFIED SECTION

    curistrelief.com

    SPRAY AT ANY ANGLE

    OZONE FRIENDLY

    NO CFCs

    PLEASE RECYCLE

    Distributed by:

    Little Pharma, Inc. | New York, NY 10023

    Made in USA with Globally Sourced Ingredients

  • PRINCIPAL DISPLAY PANEL

    curist

    Lidocaine Spray

    Maximum Strength

    Anorectal (Hemorrhoidal) Spray

    Relief of Pain, Itching, and Burning

    Numbing Spray

    With Aloe

    Net Wt. 5 oz (142 g)

    spray

  • INGREDIENTS AND APPEARANCE
    CURIST LIDOCAINE CAN 
    lidocaine spray aerosol, spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72559-023
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    ALCOHOL (UNII: 3K9958V90M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CHAMOMILE (UNII: FGL3685T2X)  
    CUCUMBER (UNII: YY7C30VXJT)  
    DISODIUM COCOAMPHODIPROPIONATE (UNII: 6K8PRP397M)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72559-023-31142 g in 1 CAN; Type 0: Not a Combination Product05/10/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM01505/10/2023
    Labeler - Little Pharma, Inc. (074328189)
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