Label: PAIN RELIEF CREAM- lidocream hydrochloride 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 January 5, 2021

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  • ACTIVE INGREDIENT

    Active Ingredient                                                                                        Purpose
    Lidocaine Hydrochloride 4%.......................................................................External Analgesic

  • Purpose

    External Analgesic

  • Warning

    For External use only

  • When using this product

    When using this product use only as directed

    • avoid 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

    Stop use and ask a doctor if condition worsens symptoms persist more than 7 days

    symptoms clear up and occur again with a few days

  • Keep out of use of children

    Keep out of use of children. If swallowed, get medical help or contact a Poison Control Center right away

  • Storage and Handling

    Apply as needed to affectedareas 3-4 times a day.

  • Inactive Ingredients

    Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Allantoin, Aqua, Arnica Mountain Flower Extract, Astaxanthin, Benzyl Alcohol, BHT, Bisabolol, Boswellia Serrata Resin Extract, Cannabis Sativa Oil/Extract, Cetyl Alcohol, Citrus Aurantium Bergamia Peel Oil, Curcurria Longa Root Extract, Cyclopentasiloxane, Dimethicone, Dimethicol, Emu Oil, Ethoxydiglycol, Glucosamine, Glycerin, Glyceryl Stearate SE, Isopropyl Palmitate, Melaleuca Alternifolia Leaf Oil, Methylsulfonylmethane, PEG-100 Stearate, Phenoxyethanol, Polyquaterium-10, Potassium Sorbate, Propylene Glycol, Retinyl Palmitate, Salicylic Acid, Sodium Hydroxide, Stearic Acid, Stearyl Alcohol, Tetrasodium EDTA, Tocopherol, Triethanolamine, Vaccinium Myrtillus Fruit/Leaf Extract

  • Indications

    Use

    For the temporary relief of pain

  • Do not use

    Do not use in large quantities, particularly over raw or blistered surfaces for more than one week without consulting a doctor

  • Ask a doctor

    Ask a doctor if condition worsens symptoms persist more than 7 days symptoms clear up and occur again with a few days

  • Directions

    Adults and children over 12 years: apply as needed to affected areas 3-4 times a day. Consult a physician if pain persists. 

  • dosage

    Apply as needed to affected areas 3-4 times a day.

  • image of label

    image of label

  • INGREDIENTS AND APPEARANCE
    PAIN RELIEF CREAM 
    lidocream hydrochloride cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:86089-222
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS3.86 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALLANTOIN (UNII: 344S277G0Z)  
    water (UNII: 059QF0KO0R)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    ASTAXANTHIN (UNII: 8XPW32PR7I)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    BISABOLOL OXIDE A (UNII: 16AE65F94Y)  
    CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CITRUS AURANTIIFOLIA FRUIT OIL (UNII: 7937R189CB)  
    CURCUMA LONGA LEAF (UNII: H2HC4RY52C)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    EMU OIL (UNII: 344821WD61)  
    ETHOXYDIGLYCOL BEHENATE (UNII: N76ISC4ZZO)  
    GLUCOSAMINE (UNII: N08U5BOQ1K)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYQUATERNIUM-10 (1000 MPA.S AT 2%) (UNII: GMR4PEN8PK)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    TETRASODIUM DIETHYLENETRIAMINEPENTAMETHYLENEPHOSPHONATE (UNII: E6DVO371LC)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    VACCINIUM MYRTILLUS LEAF (UNII: Y4U591OU70)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:86089-222-0194.6 g in 1 TUBE; Type 0: Not a Combination Product09/23/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34809/23/2019
    Labeler - AEC Consumer Products (080994102)
    Registrant - Cospro Development Corp (785638821)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cospro Development Corp785638821manufacture(86089-222) , pack(86089-222) , label(86089-222)
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