Label: ACOLYE NUMBING CREAM ANORECTAL(HEMORRHOIDAL) CREAM- lidocaine cream

  • NDC Code(s): 60771-0028-1
  • Packager: Guangzhou Haishi Biological Technology Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 9, 2025

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  • Active Ingredients

    LIDOCAINE 5%

  • Purpose

    For the temporary relief of local and anorectal itching and discomfort associated with anorectal disorders

  • Uses

    Directions
    Adults: When practical, clean the area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth before applying.Children under 12 years of age: Consult a doctor.
    Apply externally to the affected area up to 6 times daily.

  • Warnings

    For external use only

  • Stop Use

    Stop and consult a doctor if
    An allergic reaction is observed.
    Symptoms such as redness, irritation, swelling, pain, or others begin or worsen.
    Does not show improvement within 7 days.

  • Do Not Use

    on damaged or broken skin.

  • When Using

    When using this product
    Use only as much as recommended, unless a doctor advises otherwise.

    Do not insert into the rectum with fingers or any mechanical device or applicator.

  • Keep Out Of Reach Of Children

    Keep out of reach of children.
    If swallowed, get medical help or contact a Poison Control Center immediately.

  • Inactive ingredients

    Water: 82%
    Arnica: 2%
    Emu oil: 2%
    Lecithin (Soybean): 2%
    Propylene Glycol: 2%
    Tocopheryl Acetate: 2%
    Carbomer 934: 2%
    Benzyl Alcohol: 1%

  • Dosage & administration

    Squeeze out an appropriate amount of Numbing Cream and spread evenly on skin.

  • PRINCIPAL DISPLAY PANEL

    Label.

  • INGREDIENTS AND APPEARANCE
    ACOLYE NUMBING CREAM ANORECTAL(HEMORRHOIDAL) CREAM 
    lidocaine cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60771-0028
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    EMU OIL (UNII: 344821WD61)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    WATER (UNII: 059QF0KO0R)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CARBOMER 934 (UNII: Z135WT9208)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60771-0028-150 g in 1 JAR; Type 0: Not a Combination Product10/09/2025
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01510/09/2025
    Labeler - Guangzhou Haishi Biological Technology Co., Ltd. (421262738)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guangzhou Haishi Biological Technology Co., Ltd.421262738manufacture(60771-0028)
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