Label: MAXIMUM STRENGTH HEMORRHOIDAL RELIEF- lidocaine cream

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

Drug Label Information

Updated October 25, 2023

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  • Drug Facts

  • Active ingredients

    Glycerin 14.4%

    Lidocaine 5%

    Phenylephrine HCl 0.25%

    White petrolatum 15%

    Purpose

    Local anesthetic

  • Use

    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 the eyes
    • 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

    • 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 breastfeeding

    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
    • To use finger cots: Roll one finger cot over finger. Gently squeeze cream onto finger cot. Smooth a layer of the cream over affected area.
  • Other information

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

  • Inactive ingredients

    aloe oil, benzyl alcohol, carbomer 940, cholesterol, isopropyl myristate, mineral oil, polysorbate 80, propylene glycol,  purified water, trolamine, vitamin E

  • Questions?

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

  • Package Labeling:

    Outer Package02Inner Package02

  • INGREDIENTS AND APPEARANCE
    MAXIMUM STRENGTH HEMORRHOIDAL RELIEF 
    lidocaine cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51316-226
    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 TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    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:51316-226-001 in 1 BOX06/01/2022
    130 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01706/01/2022
    Labeler - CVS PHARMACY, INC (062312574)
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