Label: WALGREENS ANORECTAL LIDOCAINE CREAM- 5% lidocaine cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 May 23, 2022

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

  • Drug Fact

  • Active Ingredient

    Lidocaine 5% W/W

  • Purpose 

    Local Anesthetic 

  • Uses

    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 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

    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

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

  • Inactive ingredient

    Benzyl Alcohol, Carbomer, Cholesterol, Hydrogenated Lecithin, Isopropyl Myristate, Polysorbate 80, Propylene Glycol, Purified Water, Trolamine, Vitamin E Acetate

  • Questions ? 1- 800-222-1087

  • Principal Primary panel -Tube 

    Walgreens             NDC 0363-5722-28

    Anorectal

    Lidocaine Cream 5%

    NET WT 1 OZ (28.3g)

    280250_WAG_LAX_000000_LidocaineCream_TUBE.jpg

  • Principal Primary Panel - Carton 

    Walgreens NDC 0363-5722-28

    Anorectal

    Lidocaine Cream 5%

    NET WT 1 OZ (28.3g)

    551740_WAG_LAX_000000_LidocaineCream_BOX.jpg

  • INGREDIENTS AND APPEARANCE
    WALGREENS ANORECTAL LIDOCAINE CREAM 
    5% lidocaine cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-5722
    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
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-5722-281 in 1 CARTON04/30/2022
    128.3 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34604/30/2022
    Labeler - Walgreens Company (008965063)