Label: HEMORRHOIDAL RELIEF 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 March 10, 2021

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

  • Drug Facts

    Active ingredients

    Lidocaine USP 4%

    Phenylephrine HCL USP 0.25%

    Purpose

    Lidocaine USP 4%--------------Local Anesthetic

    Phenylephrine HCL USP 0.25%--Vasoconstrictor

    Uses

    • Helps relieve the anorectal symptoms associated with hemorrhoids (pain, soreness, burning)
    • Temporarily reduces the swelling associated with irritated hemorrhoidal tissue and other anorectal disorders

    WARNINGS

    For external use only

    Ask a doctor before use if you have

    • heart Disease
    • high blood pressure
    • thyroid disease
    • diabetes
    • difficulty in urination due to enlargement of the prostate gland

    Ask a doctor or pharmacist before use if you are

    • presently taking a prescription drug for high blood pressure or depression

    When using this product

    • do not exceed recommended daily usage 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:

    • bleeding occurs
    • condition worsens or does not improve within 7 days
    • an allergic reaction develops
    • if symptoms being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase

    If pregnant or breast-feeding

    ask a healthcare professional before use

    Keep out of reach of children:

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

    Directions

    • adults: when possible, clean affected area with mild soap or warm water, rinse thoroughly, and then gently dry (patting or blotting) with tissue or soft cloth before use
    • to use dispensing cap, attach it to the tube, lubricate well, then gentle insert part way into anus and squeeze tube to deliver medication. Thoroughly cleanse dispensing cap after use with mild soap and warm water and rinse thoroughly
    • apply to affected area upto 4 times daily, especially at night, when waking up and after each bowel movement

    Children under 12 years of age: ask a doctor

    Other information

    • store at 59 to 77 F to avoid melting

    Inactive ingredients

    .Alpha.-Tocopherol Acetate, Aloe Vera Leaf, Asian Ginseng, Calendula officinalis Flower, Chamomile, Chlorocresol, Cholecalciferol, Coconut Oil, Corn Oil, Dimethicone, Fragrance, Hyaluronate Sodium, Hydrocortisone, Lysine Hydrochloride, menthol, Mineral Oil, Petrolatum, Propylene Glycol, Pyridoxine Hydrochloride, Sunflower Oil, Tricaprilin, Vitamin A Palmitate, yellow Wax, Zinc Oxide

  • Principal Display & Drug Fact Panel

    Drug Fact Panel

  • INGREDIENTS AND APPEARANCE
    HEMORRHOIDAL RELIEF CREAM 
    lidocaine cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73622-3077
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE0.25 g  in 100 g
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE4 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ASIAN GINSENG (UNII: CUQ3A77YXI)  
    CHAMOMILE (UNII: FGL3685T2X)  
    CHLOROCRESOL (UNII: 36W53O7109)  
    CHOLECALCIFEROL (UNII: 1C6V77QF41)  
    CORN OIL (UNII: 8470G57WFM)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    LYSINE HYDROCHLORIDE (UNII: JNJ23Q2COM)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    HYDROCORTISONE (UNII: WI4X0X7BPJ)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    TRICAPRILIN (UNII: 6P92858988)  
    MENTHOL (UNII: L7T10EIP3A)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73622-3077-528.3 g in 1 TUBE; Type 0: Not a Combination Product03/04/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34603/04/2021
    Labeler - CURETECH SKINCARE (677682180)