Label: ANAL-ESE- desensitizer cream

  • NDC Code(s): 83608-106-05, 83608-106-15
  • Packager: Novelties by Nasswalk, Inc.
  • 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 24, 2023

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  • Active Ingredient:

    Benzocaine 7.5%

  • Purpose:

    Desensitizer

  • Uses:

    Desensitizing Lubricant. Where less painful anal penetration is desired.

  • Warnings:

    For External use only. Do not use near eyes. Not for prolonged use. If condition for which preparation is used causes discomfort, or if a rash or irritation should develop, discontinue use and consult a physician. For prevention of premature ejaculation.

  • Keep out of reach of children.

  • Directions:

    Apply a small amount of ANAL-ESE to rectal area prior to penetration. Wait a few minutes for desensitization before attempting penetration. Proper amount and waiting time will be determined after seferal uses.

  • Inactive Ingredients:

    PEG-8, Glycerin, PEG-75, Sodium Saccharin, Flavor, Red 40, Yellow 6

  • ANAL-ESE Cherry Flavored

    ANAL-ESE

    Cherry Flavored

    THE Original

    Net Weight 1.5 oz.

    Distributed By: Novelties by Nasswalk Inc, North Bergeb, NJ 07047. WWW.NASSTOYS.COM

    1.5 Carton

    1.5 Carton

    1.5 Tube

    1.5 Tube

    0.5 Carton

    0.5 Carton

    0.5 Tube

    0.5 Tube

  • INGREDIENTS AND APPEARANCE
    ANAL-ESE 
    desensitizer cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83608-106
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE7.5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    PEG-8 STEARATE (UNII: 2P9L47VI5E)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    PEG-75 STEARATE (UNII: OT38R0N74H)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83608-106-051 in 1 CARTON08/07/2023
    10.5 mL in 1 TUBE; Type 0: Not a Combination Product
    2NDC:83608-106-151 in 1 CARTON08/07/2023
    21.5 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34808/07/2023
    Labeler - Novelties by Nasswalk, Inc. (049455157)
    Registrant - Novelties by Nasswalk, Inc. (049455157)
    Establishment
    NameAddressID/FEIBusiness Operations
    Advance Cosmetics Research Laboratories Inc,874810872manufacture(83608-106)
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