Label: RECTAEASE HEMORRHOID RELIEF CREAM- lidocaine cream

  • NDC Code(s): 69396-070-01
  • Packager: Trifecta Pharmaceuticals USA LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 27, 2024

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

  • Drug Facts

  • Active Ingredient

    Lidocaine 5% w/w

  • Purpose

    Local Anesthetic

  • Uses

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

  • Warning Section

    For External Use Only

  • Stop use and ask a doctor

    Rectal bleeding occurs

    Condition worsens

    Symptoms persist for more than 7 days or clear up and return within a few days

    Symptoms being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase.

  • When using this product

    Avoid contact with the eyes

    do not use more than directed unless told to do so by a doctor

    do not put directly into the rectum by using fingers or any mechanical device or applicator

  • If Pregnant or Breast Feeding

    Ask doctor before use

  • Keep out of reach of children

    If swallowed get medical help or contact a Poison Control Center right away

  • Directions

    Directions:

    When practical, clean the affected area with mild soaping warm water and rinse thoroughly.

    Gently dry by patting or blotting with a toilet tissue or soft cloth before applying.

    Adult and children 12 years of age and older, apply to affected area not more than 6 times a day.

    Children under 12 years of age: do not use, ask a doctor

  • Other Information

    Store at 20º-25ºC (68º-77ºF)

  • Inactive Ingredients

    Benzyl alcohol, Carbomer 940, Cholesterol, Hydrogenated Lecithin, Isopropyl myristate, Propylene glycol,Trolamine, Vitamin E, polysorbate 80, propylene glycol, purified water

  • Questions or Comments

    Call 1-888-296-9067

  • Distributed By

    Trifecta Pharmaceuticals USA™

    101 NE Third Avenue, Suite 1500

    Ft. Lauderdale, FL. 33301, USA

    1-888-296-9067

    www.trifecta-pharma.com

  • Packaging

    4035 RECTAEASE HEMORRHID RELIEF CREAM WITH 5 PERCENT LIDOCAINE 1OZ NO FINGER COTS 022724 CDER

  • INGREDIENTS AND APPEARANCE
    RECTAEASE HEMORRHOID RELIEF CREAM 
    lidocaine cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69396-070
    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
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69396-070-011 in 1 BOX04/19/2021
    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 DrugM01504/19/2021
    Labeler - Trifecta Pharmaceuticals USA LLC (079424163)