Label: NUMB SKIN- lidocaine cream 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 9, 2022

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  • Active Ingredient

    Lidocaine 5%

  • Purpose

    Anorectal (Hemmorhoidal)

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

    Stop the use and consult doctor if:

    • allergic reaction occurs
    • rectal bleeding occurs
    • redness, irritation, swelling, pain, or other symptoms begin or increase
    • condition worsenss 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: When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with tissue or a soft cloth before application of product.
    • when first opening the tube, puncture foil seal with top end of cap
    • apply externally to the affected area up to 6 times daily
    • children under 12 years of age: consult a doctor
  • Other information

    • always keep the tube tightly closed
    • store at temperatures not exceeding 15 OC - 30 OC
    • protect from freezing
  • Inactive ingrdients

    Benzyl Alcohol, Carbomer 934, Lecithin (Soybean), Propylene Glycol, Tocopheryl Acetate, Water

  • Question or comments

    Call weekdays 9 AM to 6 PM PST at 1-844-700-6862 or email us at support@numbskin.com

  • Principal Display Panel

    NDC 70907-001-15

    FOR EXTERNAL USE ONLY

    NumbSkin Cream ®

    5% Lidocaine Cream

    Maximum Strength Pain Reliever

    NET WT. 15g

    Label

    NDC 70907-001-30

    FOR EXTERNAL USE ONLY

    NumbSkin Cream ®

    5% Lidocaine Cream

    Maximum Strength Pain Reliever

    NET WT. 30g

    Label 1

  • INGREDIENTS AND APPEARANCE
    NUMB SKIN  
    lidocaine cream cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70907-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE5 mg  in 30 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CARBOMER 934 (UNII: Z135WT9208)  
    PROPYLENE GLYCOL BUTYL ETHER (UNII: 6X8776AP5Z)  
    TOCOPHERYL RETINOATE (UNII: 0WN694NBMM)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70907-001-301 in 1 CARTRIDGE09/01/2016
    130 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:70907-001-151 in 1 CARTRIDGE04/29/2020
    215 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34609/01/2016
    Labeler - Seenext Venture Ltd (203416862)
    Registrant - Seenext Venture Ltd (203416862)
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