Label: LIDOCAINE PAIN RELIEF CREAM- 4% lidocaine cream

  • NDC Code(s): 84019-101-01, 84019-101-02, 84019-101-03, 84019-101-04, view more
    84019-101-05, 84019-101-06, 84019-101-07, 84019-101-08, 84019-101-09, 84019-101-10
  • Packager: Shengnan (Guangzhou) Cosmetics Co., LTD
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 24, 2024

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  • SPL UNCLASSIFIED SECTION

    Lidocaine Pain Relief Cream

  • ACTIVE INGREDIENT

    LIDOCAINE 4%

  • PURPOSE

    Topical Analgesic

  • INDICATIONS & USAGE

    Temporarily relieves muscle soreness and minor joint pains in the wrist, knees, back, neck, hips, shoulders, elbows.

  • WARNINGS

    For external use only

  • DO NOT USE

    On wounds or damaged skin
    With a heating pad or device
    With other ointments, creams, sprays, or liniments
    If you are allergic to any ingredients of this product

  • 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
    symptoms persist for more than 7 days

  • KEEP OUT OF REACH OF CHILDREN

    If swallowed accidentally , get medical help or contact with Poison Control Center immediately.

  • DOSAGE & ADMINISTRATION

    Children under 12: Consult a doctor.
    Adults and children 12 years and older: For optimum results cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting withl toilet tissue or a clean, soft cloth before application of this product.

  • STORAGE AND HANDLING

    Store in a dry and cool place

  • PREGNANCY OR BREAST FEEDING

    ask a health professional before use.

  • 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

    label

  • INGREDIENTS AND APPEARANCE
    LIDOCAINE PAIN RELIEF CREAM 
    4% lidocaine cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84019-101
    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
    PEG-40 HYDROGENATED LANOLIN (UNII: 959P5CXE48)  
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    MAGNESIUM DISODIUM EDTA (UNII: NDT563S5VZ)  
    PORTULACA OLERACEA SEED (UNII: M08917G08Z)  
    TETRACAINE (UNII: 0619F35CGV)  
    EPINEPHRINE (UNII: YKH834O4BH)  
    HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
    MENTHA ARVENSIS LEAF (UNII: A4IWO4DDZ9)  
    CHRYSANTHELLUM INDICUM TOP (UNII: STJ856D1Z0)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    PRILOCAINE (UNII: 046O35D44R)  
    BORNEOL (UNII: M89NIB437X)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84019-101-011 in 1 BOX01/24/2024
    130 g in 1 CANISTER; Type 0: Not a Combination Product
    2NDC:84019-101-021 in 1 BOX01/24/2024
    250 g in 1 CANISTER; Type 0: Not a Combination Product
    3NDC:84019-101-031 in 1 BOX01/24/2024
    3142 g in 1 CANISTER; Type 0: Not a Combination Product
    4NDC:84019-101-041 in 1 BOX01/24/2024
    4156 g in 1 CANISTER; Type 0: Not a Combination Product
    5NDC:84019-101-051 in 1 BOX01/24/2024
    5170 g in 1 CANISTER; Type 0: Not a Combination Product
    6NDC:84019-101-061 in 1 BOX01/24/2024
    6184 g in 1 CANISTER; Type 0: Not a Combination Product
    7NDC:84019-101-071 in 1 BOX01/24/2024
    7198 g in 1 CANISTER; Type 0: Not a Combination Product
    8NDC:84019-101-081 in 1 BOX01/24/2024
    8213 g in 1 CANISTER; Type 0: Not a Combination Product
    9NDC:84019-101-091 in 1 BOX01/24/2024
    9227 g in 1 CANISTER; Type 0: Not a Combination Product
    10NDC:84019-101-101 in 1 BOX01/24/2024
    10241 g in 1 CANISTER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01701/24/2024
    Labeler - Shengnan (Guangzhou) Cosmetics Co., LTD (541200425)
    Establishment
    NameAddressID/FEIBusiness Operations
    Shengnan (Guangzhou) Cosmetics Co., LTD541200425manufacture(84019-101)
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