NUMB SKIN (LIDOCAINE CREAM) CREAM [SEENEXT VENTURE LTD]

NUMB SKIN (LIDOCAINE CREAM) CREAM [SEENEXT VENTURE LTD]
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NDC 70907-001-30
Set ID 3ac18167-774b-3777-e054-00144ff8d46c
Category HUMAN OTC DRUG LABEL
Packager Seenext Venture Ltd
Generic Name
Product Class Amide Local Anesthetic, Antiarrhythmic
Product Number
Application Number PART346
  • 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 15OC - 30OC
    • 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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