Label: NUMB NUTS- lidocaine cream

  • 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 August 23, 2010

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    DRUG FACTS

    For Pain Relieving Cream

    Active Ingredient                     Purpose

    Lidocaine 4%                           Topical Analgesic

  • PURPOSE

    purpose
    topical analgesic
  • INDICATIONS & USAGE

    Uses

    for the temporary relief of pain associated with minor skin irritations due to groin area hair removal.

  • WARNINGS

    WARNINGS

    For external  use only.

    Avoid contact with the eyes

  • DO NOT USE

    Do not use

    with other creams or medications

    in large quantities, particularly over raw surfaces or blistered areas

    if you have had a severe allergic reaction (e.g. severe rash, hives, difficulty breathing, dizziness) to any anesthetic medicine

    if there are signs of infection or tissue damage in the affected area.

  • ASK DOCTOR

    Ask a doctor before use if you have heart or neurological conditions.

  • STOP USE

    Stop use and ask a doctor if

    you develop a persistent rash

    side effects occur

    condition worsens or symptoms persist for more than 7 days.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed get medical help or contact poison control center right away.

  • DOSAGE & ADMINISTRATION

    Directions

    For adult use only. Apply a small amount of cream to the groin area between 15 and 30 minutes prior to groin area hair removal. Do not rub in. A thin layer of cream should be visible on the skin.

  • INFORMATION FOR PATIENTS

    Other information

    Cream is packaged with an imprinted wrap around neck of tube

    do not use if carton is damaged or open, or if imprinted wrap around neck of tube is damaged or missing.

    See crimp of tube for lot number and expiration date

    Store at room temperature (68 to 77 degrees F, 20 to 25 degrees C)


  • INACTIVE INGREDIENT

    Aloe Barbadensis Leaf Juice, Caprylyl Glycol, Cetyl Alcohol, Hexylene Glycol, Phenoxyethanol, Potassium Sorbate, Simmondsia Chinesis (Jojoba) Seed Oil, Sodium Polyacrylate, Stearic Acid, Water

  • SPL UNCLASSIFIED SECTION

    Numb Nuts

    The Manscaper's Pain Relieving Cream



    Pakage contents:

    1 Tube [0.5 oz (14.2 g)] of pain relieving cream



    for more information visit

    www.numbnuts.com

  • PRINCIPAL DISPLAY PANEL

    NUMB NUTS

    The Manscapers Pain Relieving Cream

    Doctor Formulated

    Pain Relieving Cream with Aloe



    NUMB NUTS Pin Relieving Cream with Aloe

    The Manscaper's Pain Relieving Cream

    Net Wt 0.5 oz (14.2 g)

    Created and manufactured for

    Miss Smarty Pants Enterprises, Inc.

    PO Box 10446, Beverly Hills, CA 90213

    Packaging and Pain Relieving Cream-Made in the USA

  • PRINCIPAL DISPLAY PANEL

    Numb Nuts Pain Relieving Cream with aloe

    The manscapers pain relieving cream

    Net Wt 0.5 oz (14.2g)

    4% Lidocaine



    Do Not Use if imprinted wrap around neck of tube is damaged or missing.

    Created and manufactured for Miss Smarty Pants Enterprises, Inc.

    PO Box 10446 Beverly Hills, CA 90213

    Pain Relieving Cream-Made in USA



    This unit is packaged in an outer container. Please see outer container for drug facts information.



    See crimp of tube for lot number and expiration date.

    Store at room temperature (8 to 77 degrees F, 20 to 25 degrees C).

  • PRINCIPAL DISPLAY PANEL

    numbnutsouterbox

  • PRINCIPAL DISPLAY PANEL

    numbnutsdrugpanel

  • PRINCIPAL DISPLAY PANEL

    nntubelabel

  • INGREDIENTS AND APPEARANCE
    NUMB NUTS 
    lidocaine cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:48095-390
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE4 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA FLOWER (UNII: 575DY8C1ER)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    JOJOBA OIL (UNII: 724GKU717M)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    WATER (UNII: 059QF0KO0R)  
    SULISOBENZONE (UNII: 1W6L629B4K)  
    DIMETHYL SULFOXIDE (UNII: YOW8V9698H)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:48095-390-011 in 1 BOX
    114.2 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34806/10/2010
    Labeler - Miss Smarty Pants Enterprises, Inc. (942928669)
    Registrant - Miss Smarty Pants Enterprises, Inc. (942928669)
    Establishment
    NameAddressID/FEIBusiness Operations
    Miss Smarty Pants Enterprises, Inc.942928669manufacture