Label: DR. NUMB - lidocaine cream 

  • Label RSS
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 12/12

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

  • Acive Ingredients Purpose

    Lidocaine 5% Local Anesthetic

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  • 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.

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  • 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.

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  • INDICATIONS & USAGE

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

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  • 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
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  • 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
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  • INACTIVE INGREDIENT

    ​Inactive ingredients

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

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  • 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

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  • Labeling
  • INGREDIENTS AND APPEARANCE
    DR. NUMB 
    lidocaine cream
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:52512-130
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Lidocaine (Lidocaine) Lidocaine 5 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    Propylene Glycol  
    Benzyl Alcohol  
    .ALPHA.-TOCOPHEROL ACETATE  
    LECITHIN, SOYBEAN  
    CARBOMER HOMOPOLYMER TYPE B  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:52512-130-30 1 in 1 PACKAGE
    1 30 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part348 11/15/2012
    Labeler - Ei Inc. (105803274)
    Registrant - Ei Inc. (105803274)
    Establishment
    Name Address ID/FEI Business Operations
    Ei Inc. 105803274 manufacture(52512-130), label(52512-130), pack(52512-130)
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