Label: ANORECTAL LIDOCAINE CREAM- 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 September 1, 2021

If you are a consumer or patient please visit this version.

  • Active ingredient

    Lidocaine 5% w/w

  • Purpose

    Local anesthetic

  • Uses

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

  • 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 breast feeding, 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.

  • Directions

    • When practical, clean 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.

  • Other information

    Store at room temperature (20-25°C) (68-77°F). Avoid excessive heat and cold. Protect from sunlight.

  • Inactive ingredients

    benzyl alcohol, carbomer, hydrogenated lecithin, isopropyl myristate, polysorbate 80, propylene glycol, purified water, triethanolamine, vitamin E

  • Questions?

    1-800-645-2158

  • SPL UNCLASSIFIED SECTION

    Compare to the active ingredient in Recticare® Anorectal Cream††

    For the temporary relief of anorectal itching & discomfort associated with hemorrhoids

    Helps relieve pain, soreness & burning

    Highest OTC lidocaine strength available

    + 10 FINGER COTS*

    READ AND KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

    TAMPER EVIDENT: DO NOT USE IF THE TUBE IS DAMAGED OR TAMPERED WITH.

    Close cap tightly after each use.

    ††This product is not manufactured or distributed by Ferndale Healthcare®, Inc., a subsidiary of Ferndale Pharma Group, Inc., owner of the registered trademark RectiCare®.

  • Packaging

    Rugby-1339

  • INGREDIENTS AND APPEARANCE
    ANORECTAL LIDOCAINE CREAM 
    lidocaine cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1339
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE50 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0536-1339-281 in 1 CARTON09/04/2021
    128 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34609/04/2021
    Labeler - RUGBY LABORATORIES (079246066)
    Registrant - Strive Pharmaceuticals Inc. (080028013)