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

  • NDC Code(s): 60771-0029-1
  • 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 using and ask a doctor if:
    Condition worsens or does not improve within 7 days.
    An allergic reaction occurs to ingredients in this product.
    The 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.
    Keep out of reach of children.
    If swallowed, get medical help.
    If pregnant or breastfeeding, ask a health professional before use.

  • Do Not Use

    on damaged or broken skin.

  • When Using

    When using this product:
    Do not get into the eyes.
    Do not exceed recommended dosage unless directed by a doctor.
    Do not put this product into the rectum by using 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

    Adults and children 12 years and older: Apply externally to the affected area. APPLY UP TO 6 TIMES DAILY.
    Children under 12 years of age: Consult a doctor.

  • PRINCIPAL DISPLAY PANEL

    Label.

  • INGREDIENTS AND APPEARANCE
    ACOLYE NUMBING CREAM ANORECTAL(HEMORRHOIDAL) CREAM 
    lidocaine cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60771-0029
    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
    WATER (UNII: 059QF0KO0R)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    EMU OIL (UNII: 344821WD61)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    CARBOMER 934 (UNII: Z135WT9208)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60771-0029-160 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(60771-0029)
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