Label: DR. NUMB- 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 December 7, 2012

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  • Acive Ingredients Purpose

    Lidocaine 5% Local Anesthetic

  • Uses

    For temprary relief of local discomfort, itching pain, soreness or burning in the perianal area associated with anorectal disorders.For temprary relief of local discomfort, itching pain, soreness or burning in the perianal area associated with anorectal disorders.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center right away.

  • INDICATIONS & USAGE

    For temporary relief of local discomfort, itching, pain, soreness or burning in the perianal area assosiated with anorectal disorders.

  • WARNINGS

    Warnings

    For external use only

    When using this product

    • do not exceed the recommended daily dosage unless directed by a doctor
    • do not put into the rectum by using fingers or any mechanical device or applicator

    ​Stop use and ask a doctor if​

    • allergic reaction occurs
    • redness, irritation, swelling, pain, or other simptoms begin or increase
    • condition worsens or does not improve withing 7 days
  • Directions

    • adults: when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or soft cloth before application of this product
    • when first opening the tube, twist the cap and peel off the foil seal
    • apply externally to the affected area up to 6 times daily
    • children under 12 years of age: consult a doctor
  • INACTIVE INGREDIENT

    ​Inactive ingredients

    Carbopol, lecithin, propylene glycol, purified water, vitamin E.

  • SPL UNCLASSIFIED SECTION

    ​Other information​

    • always keep the tube tightly closed
    • store at temperatures not exceeding 15​0​C- 30​0​C
    • protect from freezing

    Questions and comments?

    Call weekdays 8 a.m. to 5 p.m. PST at 8-877-786-2001 oe email us at support@drnumb.com

  • Labeling

    Tube
    Unit Carton
  • INGREDIENTS AND APPEARANCE
    DR. NUMB 
    lidocaine cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52512-130
    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
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Benzyl Alcohol (UNII: LKG8494WBH)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    CARBOMER HOMOPOLYMER TYPE B (UNII: HHT01ZNK31)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52512-130-301 in 1 PACKAGE
    130 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34811/15/2012
    Labeler - Ei Inc. (105803274)
    Registrant - Ei Inc. (105803274)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ei Inc.105803274manufacture(52512-130) , label(52512-130) , pack(52512-130)
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