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 November 7, 2022

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  • Active ingredient

    Lidocaine 5% w/w

  • Purpose

    Anorectal (Hemorrhoidal)

  • Uses

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

  • Warnings

    For external use only

    When using this product

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

    Stop the use and consult doctor if

    • allergic reaction occurs
    • rectal bleeding occurs
    • redness, irritation, swelling, pain or other symptoms begin or increase
    • condition worsens or does not improve within 7 days

    KEEP OUT OF REACH OF CHILDREN

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

  • Directions

    Adults and Children 12 years and older: 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 a soft cloth before application of this product. Apply to the affected area up to 6 times a day.

    Children under 2 years: Consult a doctor

  • Other Information

    • always keep the tube tightly closed
    • Store at temperatures not exceeding 15° C-30°C (59° F-86° F)
    • Protect from freezing
  • Inactive Ingredients

    Benzyl Alcohol, Carbopol, Lecithin, Propylene Glycol, Tocopheryl Acetate, Water.

  • Questions or Comments

    Contact our dedicated Customer Care at +1(877) 786 2001 or email us at support@shinpharma.com

  • Principal Display Panel

    NDC 69903-004-10

    Dr. Numb®

    Lidocaine Cream

    RAPID ABSORPTION!

    Maximum Strength Pain Reliever

    10g

    Label

  • INGREDIENTS AND APPEARANCE
    DR. NUMB 
    lidocaine cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69903-004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE0.5 g  in 10 g
    Inactive Ingredients
    Ingredient NameStrength
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69903-004-101 in 1 CARTON05/29/2019
    110 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34605/29/2019
    Labeler - Shinpharma Inc (248552403)
    Registrant - Shinpharma Inc (248552403)
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