Label: CURIST LIDOCAINE RELIEF- lidocaine 5% cream

  • 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 March 13, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient

    Lidocaine 5%

  • PURPOSE

    Purpose

    Anorectal (hemorrhoidal) cream

  • INDICATIONS & USAGE

    Uses
    helps relieve itching and discomfort associated with hemorrhoids

  • WARNINGS

    Warnings
    For external use only

    When using this product

    • avoid contact with eyes
    • do not exceed recommended dosage unless directed by a 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

    • when practical, clean affected area with mild soap and warm water and rinse thoroughly
    • Gently dry by patting or blotting with toilet tissue or soft cloth before applying
    • adults and children 12 years and older: apply externally to the affected area up to 6 times a day
    • 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 benzyl alcohol, calendula officinalis flower extract, carbomer, carya ovata bark extract, centella asiatica extract, chamomile flower extract, cholesterol, helichrysum italicum extract, horse chestnut extract, hydrogenated lecithin, isopropyl myristate, lavender flower extract, olive leaf extract, panax ginseng root extract, polysorbate 80, propylene glycol, rosemary leaf extract, sodium hyaluronate, tea tree leaf extract, tocopheryl acetate, triethanolamine, turmeric root extract, water, witch hazel leaf extract

  • SPL UNCLASSIFIED SECTION

    curistrelief.com

    PEEL HERE FOR DRUG FACTS

    Distributed by:
    Little Pharma, Inc.
    New York, NY 10023 | Made in USA

    With Globally Sourced Ingredients

    Save 20%

    Use code

    LIDOCAINE20

    on your next bottle at

    curistrelief.com

    Limit one per customer.

  • QUESTIONS

    Questions or comments?

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

  • PRINCIPAL DISPLAY PANEL

    curist
    Lidocaine Relief
    Lidocaine 5% Anorectal (Hemorrhoidal) Cream
    Relief of Pain, Itching and Burning; with Essential Extracts


    Net Wt. 2 oz (57 g)

    Lidocaine Relief image

  • INGREDIENTS AND APPEARANCE
    CURIST LIDOCAINE RELIEF 
    lidocaine 5% cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72559-024
    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
    HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    ROSEMARY (UNII: IJ67X351P9)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    HELICHRYSUM ITALICUM FLOWER (UNII: P62Y550X24)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    LAVANDULA ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)  
    TURMERIC (UNII: 856YO1Z64F)  
    WATER (UNII: 059QF0KO0R)  
    HAMAMELIS VIRGINIANA LEAF (UNII: T07U1161SV)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    CARYA OVATA BARK (UNII: X765CF609L)  
    CENTELLA ASIATICA TRITERPENOIDS (UNII: 4YS74Q4G4J)  
    CHAMOMILE (UNII: FGL3685T2X)  
    HORSE CHESTNUT (UNII: 3C18L6RJAZ)  
    OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)  
    ASIAN GINSENG (UNII: CUQ3A77YXI)  
    Product Characteristics
    Colorwhite (White to off-white) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72559-024-3257 g in 1 JAR; Type 0: Not a Combination Product02/23/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM01502/23/2023
    Labeler - Little Pharma, Inc. (074328189)
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