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
  • 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 April 14, 2022

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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, Carbopol 940, Hydrogenated Lecithin, Isopropyl Myristate, Polysorbate 80, Propylene Glycol, Purified Water, Trolamine, and Vitamin E Acetate

  • Questions?

    Call 800-936-3088

  • PRINCIPAL DISPLAY PANEL - 15 gram Tube Carton

    NDC 39328-025-15

    Lidocaine
    5%
    Anorectal Cream

    PATRIN
    PHARMA

    NET WT. 15 grams

    PRINCIPAL DISPLAY PANEL - 15 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 finalpart34611/01/2018
    Labeler - Patrin Pharma Inc. (806841677)
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