Label: HEMORRHOIDAL WITH LIDOCAINE- glycerin, lidocaine, phenylephrine hydrochloride, white petrolatum cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 24, 2023

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  • Drug Facts

  • Active ingredients

    Glycerin 14.4%

    Lidocaine 5%

    Phenylephrine HCl 0.25%

    White petrolatum 15%

    Purpose

    Protectant

    Local anesthetic

    Vasoconstrictor

    Protectant

  • Use

    • for temporary relief of pain, soreness and burning
    • helps relieve the local itching and discomfort associated with hemorrhoids
    • temporarily provides a coating for relief of anorectal discomforts
    • temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful
    • temporarily shrinks hemorrhoidal tissue
  • Warnings

    For external use only.

    Ask a doctor before use if you have

    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
    • diffficulty 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 the recommended daily dosage unless directed by a doctor
    • do not put 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
    • the 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.

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

  • Directions

    Adults:

    • when practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe. Gently dry by patting or blotting with a tissue or a soft cloth before applying this cream.
    • apply externally to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement
    • children under 12 years of age: ask a doctor.
  • Other information

    store at room temperature 68° - 77° F (20° - 25° C)

  • Inactive ingredients

    aloe oil, cetearyl alcohol, citric acid monohydrate, dexpanthenol, ethylenediaminetetraacetic acid disodium salt, glyceryl monostearate, methylparaben, mineral oil, octadecyl alcohol, polysorbate 80, propyl 4-hydroxybenzoate, propylene glycol, purified water, vitamin E

  • Questions?

    1-800-639-3803 Weekdays 9 AM to 4 PM EST

  • Package Labeling:

    Outer PackageInner Package

  • INGREDIENTS AND APPEARANCE
    HEMORRHOIDAL WITH LIDOCAINE 
    glycerin, lidocaine, phenylephrine hydrochloride, white petrolatum cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51316-225
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN144 mg  in 1 g
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE50 mg  in 1 g
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE2.5 mg  in 1 g
    WHITE PETROLATUM (UNII: B6E5W8RQJ4) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE150 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    DEXPANTHENOL (UNII: 1O6C93RI7Z)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51316-225-001 in 1 BOX06/01/2022
    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 DrugM01606/01/2022
    Labeler - CVS PHARMACY, INC (062312574)
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