Label: BRAZZERS ANAL DESENSITIZING- lidocaine cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 6, 2023

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  • Drug Facts

  • Active Ingredient

    Lidocaine 2%

    Purpose

    Anorectal

  • Use (s)

    For temporary relief of pain, soreness or burning in the peritanal area.

  • Warnings:

    For external use only.

    Do not use

    this product with a mechanical device. Certain persons can develop allergic reactions to ingredients in this product. If the symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase, discontinue use and consult a doctor. Do not apply onto cracked or broken skin. 

    Keep out of reach of children.

    In case of any bleeding, discontinue use and consult a doctor. As with any drug, consult a health care professional.

  • Directions

    Cleanse affected area with mild soap and water. Gently dry before application. Apply externally to the affected area up to 6 times daily.

  • Other Information:

    • Store at room temperture 68-77 °F (20-25 °C).
    • Do not use if temper evident seal on the outside of the container is broken or missing.
  • Inactive Ingredients:

    Water, Dimethicone, Cetearyl Alcohol, Caprylic/Capric Triglyceride, Lidocaine, Glyceryl Stearate, Propylene Glycol, Ceteareth-20, 1,2-Hexanediol, Hydroxyacetophenone, Dimethiconal, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Xanthan Gum, Sodium Hydroxide.

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    BRAZZERS ANAL DESENSITIZING 
    lidocaine cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83553-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE20 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83553-001-0029.6 mL in 1 BOTTLE; Type 0: Not a Combination Product07/06/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01507/06/2023
    Labeler - Metro Media Ent (089682591)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bath Concept Cosmetics (Dongguan) Co., Ltd529623933manufacture(83553-001)
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