Label: HEMORRHOID RELIEF CREAM- lidocaine 5% anorectal cream

  • NDC Code(s): 73492-712-28
  • Packager: ALAINA HEALTHCARE PRIVATE LIMITED
  • 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 January 28, 2022

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, itching, and burning, associated with hemorrhoids and anorectal disorders.

  • Warnings  For external use only 

        When using this product 

    • use only as directed.
    • Avoid contact with eyes. 
    • do not exceed recommended dosage unless directed by a doctor. 
    • do not out 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. 
    • symptoms clear up and occur again within a few days. 
    • an allergic reaction develops 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 breast-feeding, ask a health professional before use.
  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of children and pets. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • Directions

    Adult and children 12 years and over:

    • When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly, gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product.
    • apply externally to the affected area up to 6 times a day children under 12 years of age: consult a doctor.
  • Other Information.

    • Store between 15°-30° C (59°-30° F).
  • Inactive Ingredient

    Benzyl Alcohol, Carbomer 940, Cholesterol, Isopropyl Myristate, Lecithin (Soya), Polysorbate 80, Propylene Glycol, Purified Water, Triethanolamine, Vitamin-E Acetate.

  • Questions or Comments? 1-888-287-1915

  • SPL UNCLASSIFIED SECTION

    Manufactured By:
    Alaina Healthcare Private Limited
    Khasra No. 127-133, Baddi-Barotiwala Road,
    Baddi, HIMACHAL PRADESH 173205, India (IND).

    Distributed By:
    Walmart Inc., Bentonville, AR 72716. PRODUCT OF INDIA.

    *This product is not manufactured or distributed by Ferndale IP, Inc., Owner of the registered trademark RectiCare ®.

  • Package Label.Principal Display Panel

    Hemorrhoid Relief Cream-Tube - NDC 73492-712-28 - Label.

    Hemorrhoid Relief Cream-Tube - NDC 73492-712-28 - Label.

    Hemorrhoid Relief Cream-Tube - NDC 73492-712-28 - Carton.

    Hemorrhoid Relief Cream-Tube - NDC 73492-712-28 - Carton.
  • INGREDIENTS AND APPEARANCE
    HEMORRHOID RELIEF CREAM 
    lidocaine 5% anorectal cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73492-712
    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 940 (UNII: 4Q93RCW27E)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73492-712-281 in 1 CARTON01/28/2022
    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 finalpart34601/28/2022
    Labeler - ALAINA HEALTHCARE PRIVATE LIMITED (858720927)
    Establishment
    NameAddressID/FEIBusiness Operations
    ALAINA HEALTHCARE PRIVATE LIMITED858720927manufacture(73492-712)