Label: ANECREAM 5- lidocaine 5% cream

  • NDC Code(s): 24357-702-15, 24357-702-30
  • Packager: Focus Health Group
  • 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 December 13, 2022

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  • 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 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 of blotting with toilet tissue or soft cloth before applying.
    • Adults and children 12 years and older: Apply to the affected area up to 6 times a day.
    • Children under 12 years of age: Consult a doctor.
  • Other information

    Store at USP controlled room temperature 20-25C (66-77F).

  • Inactive ingredients

    benzyl alcohol, carbomer 940, cholesterol, hydrogenated lecithin, isopropyl myristate, polysorbate 80, propylene glycol, tocopheryl acetate, trolamine, water.


  • Anecream5 15g Tube Carton

    Anecream 5 15g

    AC 5art 15gm.jpg

    The product package shown above represents a sample of that currently in use. Additional packaging may also be available.

    Anecream5 Anorectal Cream

    Net. Wt. 15g

    Distributed by: Focus Health Group

    Knoxville, TN 37919

    Anecream5 15g Tube Carton

  • INGREDIENTS AND APPEARANCE
    ANECREAM 5 
    lidocaine 5% cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24357-702
    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
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24357-702-151 in 1 CARTON12/20/2011
    115 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:24357-702-301 in 1 CARTON05/21/2019
    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 finalpart34612/20/2011
    Labeler - Focus Health Group (826939949)
    Registrant - DSC Laboratories Inc. (097807374)
    Establishment
    NameAddressID/FEIBusiness Operations
    DSC Laboratories, Inc.097807374manufacture(24357-702)
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