Label: BEAUELI- lidocaine cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 August 18, 2023

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

  • Active ingredients

    Lidocaine 5%

  • Purpose

    Local Anesthetic

  • Uses

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

  • Warnings

    For external use only

    When using this product

    • Do not get into eyes.
    • Do not exceed recommend dosage unless directed by doctor.
    • Do not put this product into rectum by using fingers or any mechanical device or applicator.

    Stop use and ask a doctor if

    • 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.

    Keep out of reach of children.If swallowed, get medical help. Do not use if allergic to any ingredients.

    If pregnant or breastfeedingask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

  • Directions

    • When practical clean area with mild soap and warm water and rinse thoroughly. Gently dry by patting or bloating 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 on to finger cot. Smooth a layer of the cream.
  • Other information

    Store at room temperature. Avoid direct sunlight. Do not use if temper evident packaging has been breached or is missing.

  • INACTIVE INGREDIENT

    water, glycerine, Lidocaine Lsopropyl palmitate, Aloe barbadensis leaf juice, Retinol,Helianthus annuus (sunflower)seed oil, Glyceryl stearate,
    Pentylene glycol, Butyrospermum parkii (shea)butter,Cetyl alcohol, Piper methysticum leaf/root/stem extract, Peg-100 stearate, Tocopheryl acetate.

  • Product label

    image description

  • INGREDIENTS AND APPEARANCE
    BEAUELI 
    lidocaine cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83462-001
    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)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALOE (UNII: V5VD430YW9)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    RETINOL (UNII: G2SH0XKK91)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    PIPER METHYSTICUM WHOLE (UNII: 3P306S300W)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83462-001-0150 g in 1 BOTTLE; Type 0: Not a Combination Product07/01/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34807/01/2023
    Labeler - EUbizrival LLC (036572203)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guangzhou Pallas Cosmetics Co.,Ltd.419564106manufacture(83462-001)