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

  • Category: HUMAN OTC DRUG LABEL

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated April 24, 2023

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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

  • PRINCIPAL DISPLAY PANEL - 77 g Tube Carton Label

    NERVE DESENSITIZING
    PAIN RELIEF CREAM

    BLUE-EMU®

    Fast Acting
    Odor Free
    + Emu Oil

    Lidocaine
    Numbing

    Hands-Free
    SOFT SPONGE
    APPLICATOR

    New!
    Easy Open
    Cap Design

    AMERICA'S
    #1 EMU OIL FORMULA
    ODOR
    FREE

    Contains Emu Oil

    NET WT 2.7 OZ (77g)

    PRINCIPAL DISPLAY PANEL - 77 g Tube Carton
  • 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 not finalpart34803/01/2017
    Labeler - NFI, LLC (121681919)
    Establishment
    NameAddressID/FEIBusiness Operations
    Gregory Pharmaceutical Holdings, Inc., dba UPM Pharmaceuticals081301372MANUFACTURE(69993-350)
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