TOPICAL ANESTHETIC ANORECTAL CREAM NUMB AND NUMBER (LIDOCAINE) CREAM [DERMTECH LABS INC. DBA GD LABS]

TOPICAL ANESTHETIC ANORECTAL CREAM NUMB AND NUMBER (LIDOCAINE) CREAM [DERMTECH LABS INC. DBA GD LABS]
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NDC 68848-001-01, 68848-001-02, 68848-001-03, 68848-001-04
Set ID 1a99fa0e-a6c2-499f-81d4-79e2d052ff74
Category HUMAN OTC DRUG LABEL
Packager Dermtech Labs Inc. dba GD Labs
Generic Name
Product Class Amide Local Anesthetic, Antiarrhythmic
Product Number
Application Number PART346
  • ACTIVE INGREDIENT

    Active Ingredient     Purpose
    Lidocaine 5%  ..... Topical Anesthetic

  • PURPOSE

    Temporarily relieves local pain and discomfort of anorectal area.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of Chilren

  • INDICATIONS & USAGE

    Stop use and ask your doctor if rectal bleeding occurs, condition worsens or does not improve within 7 days.

  • WARNINGS

    • For Rectal use only
    • For external use on intact skin only
    • Do not use if pregnant or breast-feeding
    • Do not exceed the recommended daily dosage unless directded by a doctor
    • Avoid contact with eyes and mucous membranes
    • You may experience temporary redness or stinging where the product is applied
    • If irritation persists, consult your doctor
    • Do not put product into the rectum by using fingers or any mechanical device or applicator
  • DOSAGE & ADMINISTRATION

    • Children 12 and under, consult a physician prior to use
    • When practical, clean area with mild soap and water. Rinse thoroughly and gently dry by blotting with tissue or soft cloth before applying.
    • Apply to the affected area up to 6 times daily
  • INACTIVE INGREDIENT

    Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Benzyl Alcohol, Ceteareth-20, Cetearyl Alcohol, Cholesterol, Ethoxydiglycol, Lecithin, Polysorbate-80, PPG-12/SMDI Copolyme, Propylene Glycol, Trolamine, Water

  • PRINCIPAL DISPLAY PANEL

    Numb & Number

    Topical Anesthetic

    Anorectal Cream

    Net Wt 20 oz / 600g

    label

  • INGREDIENTS AND APPEARANCE
    TOPICAL ANESTHETIC ANORECTAL CREAM  NUMB AND NUMBER
    lidocaine cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68848-001
    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
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
    HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PPG-12/SMDI COPOLYMER (UNII: 1BK9DDD24E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68848-001-021 in 1 PACKAGE08/11/2016
    1NDC:68848-001-0154 g in 1 PACKAGE; Type 0: Not a Combination Product
    2NDC:68848-001-041 in 1 PACKAGE08/11/2016
    2NDC:68848-001-03600 g in 1 PACKAGE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34608/11/2016
    Labeler - Dermtech Labs Inc. dba GD Labs (148077899)
    Registrant - Dermtech Labs Inc. dba GD Labs (148077899)
    Establishment
    NameAddressID/FEIBusiness Operations
    VEGE-KURL, INC021072509manufacture(68848-001)

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