Label: BLUE-EMU LIDOCAINE PAIN RELIEF CREAM- lidocaine cream 4% cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated May 17, 2024

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  • Active Ingredients

    Lidocaine HCl 4%

  • Purpose

    Topical anesthetic

  • Uses

    temporarily relieves minor pain

  • Warnings

    For external use only

    Do not use

    • on large areas of the body or on cut, irritated or swollen skin
    • on puncture wounds
    • for more than one week without consulting a doctor

    When using this product

    • use only as directed. Read and follow all directions and warnings on this carton.
    • do not allow contact with the eyes
    • do not bandage or apply local heat (such as heating pads) to the area of use

    Stop use and ask a doctor if

    • condition worsens
    • symptoms persist for more than 7 days or clear up and occur again within a few days

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

    Keep out of reach of children and pets.If swallowed, get medical help or contact Poison Control Center right away.

  • Directions

    Adults and children over 12 years:

    • apply a thin layer to affected area every 6 to 8 hours, not to exceed 3 applications in a 24 hour period

    Children 12 years or younger:ask a doctor

  • Inactive Ingredients

    acrylates acrylamide copolymer, aloe barbadensis leaf juice (aloe vera), allantoin, caprylic capric triglyceride, cetyl alcohol, dl-panthenol, dimethicone, ethylhexylglycerin, emu oil, glycerin, glyceryl stearate, mineral oil, phenoxyethanol, polyethylene glycol 100 stearate, polysorbate 80, polysorbate 85, sodium polycrylate, stearic acid, triethanolamine, tocopherol acetate (Vitamin E), water.

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY: NFI CONSUMER PRODUCTS
    501 Fifth Street • Bristol, TN 37620 • 1-800-432-9334
    WWW.BLUE-EMU.COM

  • Product label

    image description

  • INGREDIENTS AND APPEARANCE
    BLUE-EMU LIDOCAINE PAIN RELIEF CREAM 
    lidocaine cream 4% cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69993-350
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS40 mg
    Inactive Ingredients
    Ingredient NameStrength
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    WATER (UNII: 059QF0KO0R)  
    CAPRYLIC/CAPRIC/LINOLEIC TRIGLYCERIDE (UNII: U73D397055)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    EMU OIL (UNII: 344821WD61)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PEG-120 GLYCERYL STEARATE (UNII: 6941286E4I)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    POLYSORBATE 85 (UNII: A7F3N56197)  
    SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALLANTOIN (UNII: 344S277G0Z)  
    CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69993-350-031 in 1 CARTON03/01/2017
    177 in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01703/01/2017
    Labeler - NFI, LLC (121681919)
    Establishment
    NameAddressID/FEIBusiness Operations
    Gregory Pharmaceutical Holdings, Inc., dba UPM Pharmaceuticals081301372manufacture(69993-350)
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