Label: LIDOCAINE ANORECTAL- lidocaine cream

  • NDC Code(s): 39328-025-15, 39328-025-30
  • Packager: Patrin Pharma, Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 13, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Lidocaine 5% w/w

  • Purpose

    Local anesthetic

  • Uses

    Temporarily relieves pain and itching due to anorectal disorders

  • Warnings

    When using this product

    • Avoid contact with eyes
    • Do not exceed recommended dosage unless directed by a doctor

    Stop use and ask a doctor if

    • Rectal bleeding occurs
    • Condition worsens or does not improve within 7 days
    • Allergic reaction occurs
    • Redness, irritation, swelling, pain or other symptoms begin or increase
    • Symptoms clear up and return within a few days

    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
  • Other information

    • Store at room temperature 20–25°C (68–77°F); Excursions permitted 15–30°C (59–86°F) [see USP Controlled Room Temperature].
  • Inactive ingredients

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

  • Questions?

    Call 800-936-3088

  • PRINCIPAL DISPLAY PANEL - 30 gram Tube Carton

    NDC 39328-025-30

    Lidocaine
    5%
    Anorectal Cream

    PATRIN
    PHARMA

    Net Wt. 30 grams

    PRINCIPAL DISPLAY PANEL - 30 gram Tube Carton
  • INGREDIENTS AND APPEARANCE
    LIDOCAINE ANORECTAL 
    lidocaine cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:39328-025
    Route of AdministrationRECTAL
    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)  
    HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
    Isopropyl Myristate (UNII: 0RE8K4LNJS)  
    Polysorbate 80 (UNII: 6OZP39ZG8H)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    Trolamine (UNII: 9O3K93S3TK)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:39328-025-151 in 1 CARTON11/01/2018
    115 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:39328-025-301 in 1 CARTON11/01/2018
    230 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph drugM01511/01/2018
    Labeler - Patrin Pharma, Inc (806841677)
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