Label: CURIST HEMORRHOID RELIEF- lidocaine 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 July 25, 2022

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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 the pain, itching and burning associated with hemorrhoids and other anorectal disorders.

  • 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.
    • symptoms clear up and return within a few days.

    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 the 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, carbomer, cholesterol, hydrogenated lecithin, isopropyl myristate, polysorbate 80, propylene glycol, tocopheryl acetate, triethanolamine, water.

  • QUESTIONS

    Questions? 1-844-243-1241

  • SPL UNCLASSIFIED SECTION

    Distributed by:

    Little Pharma, Inc.

    New York, NY 10023

    Made in USA With Globally Sourced Ingredients

  • PRINCIPAL DISPLAY PANEL

    curist

    Hemorrhoid Relief

    Lidocaine 5% Cream

    Anorectal (Hemorrhoidal) Cream

    Relief of Pain, Itching and Burning

    Net. Wt. 6 oz (170 g)

    Hemorrhoid Relief 72559-018

  • INGREDIENTS AND APPEARANCE
    CURIST HEMORRHOID RELIEF 
    lidocaine cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72559-018
    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)  
    WATER (UNII: 059QF0KO0R)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Product Characteristics
    Colorwhite (White to Off-white) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72559-018-151 in 1 CARTON01/20/2022
    1170 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34601/20/2022
    Labeler - Little Pharma, Inc. (074328189)
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