Label: LIDOCAINE PAIN RELIEF WITH LAVENDER- lidocaine hydrochloride liquid

  • NDC Code(s): 66902-057-03
  • Packager: Natural Essentials, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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 May 30, 2023

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  • Active ingredient

    Lidocaine HCl 4%

  • Purpose

    Topical anesthetic

  • Use

    • For the temporary relief of 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 area of use

    Stop use and ask a doctor if

    • conditions worsen
    • skin reactions occur, such as rash, itching, redness, irritation, pain, swelling and blistering
    • symptoms persist for more than 7 days
    • symptoms dear up and occur again within a few days

    Flammable: Keep away from fire or flame

    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 a Poison Control Center right away.

  • Directions

    • adults and children 12 years of age and over:
    • 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

  • Other information

    • Avoid storing product in direct sunlight
    • Protect product from excessive moisture
    • Store with lid closed tightly
  • Inactive ingredients

    Acrylates/C10-30 Acrylate Crosspolymer, Alcohol Denatured, Aloe Barbadensis Leaf Juice, Aminomethyl Propanol, C30-45 Alkyl Cetearyl Dimethicone Crosspolymer, Caprylyl Methicone, Cetearyl Alcohol, Ceteth-20 Phosphate, Dicetyl Phosphate, Dimethicone, Disodium EDTA, Ethylhexylglycerin, Glyceryl Stearate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Isohexadecane, Lavandula Angustifolia (Lavender) Oil, Methylparaben, Polysorbate 60, Steareth-2, Steareth-21, Water

  • Principal Display Panel – 73 mL Carton Label

    CVS
    Health®

    Compare to the active
    ingredient in Aspercreme®
    Lidocaine with Lavender
    Essential Oil*

    MAXIMUM STRENGTH
    Lidocaine concentration
    without a prescription    †

    Lidocaine
    Pain Relief
    Roll-On

    LIDOCAINE HCI 4%

    Lavender Essential Oil

    • Temporary relief of pain
    • Helps numb pain-affected
      areas without irritation
    • Non-greasy, no-mess formula

    With calming
    lavender
    aromatherapy

    Actual Bottle
    Size on
    Side Panel

    2.5 FL OZ
    (73 mL)

    Principal Display Panel – 73 mL Carton Label
  • Principal Display Panel – 73 mL Bottle Label

    CVS
    Health®

    MAXIMUM STRENGTH
    Lidocaine concentration
    without a prescription    †

    Lidocaine Pain
    Relief Roll-On

    LIDOCAINE HCI 4%

    Lavender Essential Oil

    With calming
    lavender
    aromatherapy

    2.5 FL OZ (73 mL)

    Principal Display Panel – 73 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    LIDOCAINE PAIN RELIEF WITH LAVENDER 
    lidocaine hydrochloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66902-057
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) Lidocaine Hydrochloride Anhydrous38 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36)  
    ALCOHOL (UNII: 3K9958V90M)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETETH-20 PHOSPHATE (UNII: 921FTA1500)  
    DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    STEARETH-2 (UNII: V56DFE46J5)  
    STEARETH-21 (UNII: 53J3F32P58)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66902-057-031 in 1 CARTON01/22/2021
    173 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34801/22/2021
    Labeler - Natural Essentials, Inc. (947484713)
    Establishment
    NameAddressID/FEIBusiness Operations
    NATURAL ESSENTIALS, INC.947484713MANUFACTURE(66902-057)
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