Label: NUMB CREAM- lidocaine cream

  • NDC Code(s): 84019-301-01, 84019-301-02, 84019-301-03, 84019-301-04, view more
    84019-301-05, 84019-301-06, 84019-301-07, 84019-301-08, 84019-301-09, 84019-301-10, 84019-301-11
  • Packager: Shengnan (Guangzhou) Cosmetics Co., LTD
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated March 6, 2024

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  • SPL UNCLASSIFIED SECTION

    Numb Cream

  • ACTIVE INGREDIENT

    LIDOCAINE 4%

  • PURPOSE

    Topical Analgesic

  • INDICATIONS & USAGE

    For temporarily relieve local discomfort, itching, pain, soreness or burning sensation on hands, legs, back and other skin.

  • WARNINGS

    For external use only

  • DO NOT USE

    lf pregnant or breast-feeding, ask a health professional before use.

  • WHEN USING

    Use only as directed.
    Avoid contact with the eyes,
    mucous membranes, or rashes.
    Do not bandage tightly.

  • STOP USE

    skin reactions such as redness.swelling, blistering or other discomfort occur.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN.
    lf swallowed accidentally, get medical help or contact with Poison Control Center immediately.

  • DOSAGE & ADMINISTRATION

    1.For optimum results cleanse the affected area with mild soap and warm water and rinse thoroughly.
    2.Apply externally to the affected area up to 6 times.

  • INACTIVE INGREDIENT

    Water
    Propylene Glycol
    Carbomer
    Glycerin
    Disodium Edta
    Hydroxyacetophenone
    1.2-Hexanediol
    Mentha Arvensis Leaf Extract
    Chrysanthellum Indicum Extract
    Portulaca Oleracea Extract
    Peg-40 Hydrogenated Castor Oil
    Epinephrine
    Tetracaine
    Prilocaine
    Borneol

  • PRINCIPAL DISPLAY PANEL

    label1

  • INGREDIENTS AND APPEARANCE
    NUMB CREAM 
    lidocaine cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84019-301
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE4 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    MENTHA ARVENSIS LEAF (UNII: A4IWO4DDZ9)  
    PORTULACA OLERACEA SEED (UNII: M08917G08Z)  
    WATER (UNII: 059QF0KO0R)  
    PRILOCAINE (UNII: 046O35D44R)  
    HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
    CHRYSANTHELLUM INDICUM TOP (UNII: STJ856D1Z0)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    TETRACAINE (UNII: 0619F35CGV)  
    EPINEPHRINE (UNII: YKH834O4BH)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    MAGNESIUM DISODIUM EDTA (UNII: NDT563S5VZ)  
    BORNEOL (UNII: M89NIB437X)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    PEG-40 HYDROGENATED LANOLIN (UNII: 959P5CXE48)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84019-301-011 in 1 BOX02/22/2024
    110 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:84019-301-021 in 1 BOX02/22/2024
    230 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:84019-301-031 in 1 BOX02/22/2024
    350 g in 1 TUBE; Type 0: Not a Combination Product
    4NDC:84019-301-041 in 1 BOX02/22/2024
    460 g in 1 TUBE; Type 0: Not a Combination Product
    5NDC:84019-301-051 in 1 BOX02/22/2024
    5100 g in 1 TUBE; Type 0: Not a Combination Product
    6NDC:84019-301-061 in 1 BOX02/22/2024
    6120 g in 1 TUBE; Type 0: Not a Combination Product
    7NDC:84019-301-071 in 1 BOX02/22/2024
    7150 g in 1 TUBE; Type 0: Not a Combination Product
    8NDC:84019-301-081 in 1 BOX02/22/2024
    8200 g in 1 TUBE; Type 0: Not a Combination Product
    9NDC:84019-301-091 in 1 BOX02/22/2024
    9250 g in 1 TUBE; Type 0: Not a Combination Product
    10NDC:84019-301-101 in 1 BOX02/22/2024
    10300 g in 1 TUBE; Type 0: Not a Combination Product
    11NDC:84019-301-111 in 1 BOX02/22/2024
    11500 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01702/22/2024
    Labeler - Shengnan (Guangzhou) Cosmetics Co., LTD (541200425)
    Establishment
    NameAddressID/FEIBusiness Operations
    Shengnan (Guangzhou) Cosmetics Co., LTD541200425manufacture(84019-301)
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