Label: NERVIVE PAIN RELIEVING CREAM- lidocaine hcl and menthol cream

  • NDC Code(s): 84126-318-03
  • Packager: The Procter & Gamble Manufacturing Company
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated August 6, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    Lidocaine HCl 4%

    Menthol 1%

    Purpose

    Topical anesthetic

    Topical analgesic

  • Use

    temporarily relieves minor pain

  • Warnings

    For external use only
    Flammable

    • keep away from heat and open flame

    Do not use

    • If you have had an allergic reaction to lidocaine or other local anesthetics
    • on large areas of the body or on cut, irritated, blistered, 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.
    • avoid contact with eyes and mucous membranes
    • rare cases of serious burns have been reported with products of this type
    • do not apply to wounds or damaged, broken or irritated skin
    • do not bandage tightly or apply local heat (such as heating pads) or a medicated patch to the area of use
    • a transient burning sensation may occur upon application but generally disappears in several days
    • avoid applying into skin folds

    Stop use and ask a doctor if

    • condition worsens
    • severe burning sensation, redness, rash or irritation develops
    • symptoms persist for more than 7 days or clear up and occur again within a few days
    • you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied

    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 over 12 years:

    • apply a thin layer to affected area every 6 to 8 hours
    • do not exceed 3 applications in a 24 hour period
    • massage into painful area until thoroughly absorbed into skin

    AFTER APPLYING, WASH HANDS WITH SOAP AND WATER
    children 12 years or younger: ask a doctor

  • STORAGE AND HANDLING

    Store at no greater than 25°C (77°F).

  • Inactive ingredients

    acrylates/C10-30 alkyl acrylate crosspolymer, alcohol, aminomethylpropanol, C30-45 alkyl cetearyl dimethicone crosspolymer, caprylyl
    methicone, ceteth-20 phosphate, cetostearyl alcohol, dicetyl phosphate, dimethicone, edetate disodium, ethylhexylglycerin, glyceryl stearate, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, isohexadecane, phenoxyethanol, polyoxyl 15 hydroxystearate, polysorbate 60, sorbitan isostearate, steareth-21, tocopherol, water

  • Questions?

    1-855-446-4345

  • SPL UNCLASSIFIED SECTION

    DIST. BY: PROCTER & GAMBLE, CINCINNATI, OH 45202

  • PRINCIPAL DISPLAY PANEL - 3.0 OZ

    NERVIVE™

    PAIN RELIEVING CREAM

    LIDOCAINE HCl & MENTHOL

    TARGETS MULTIPLE

    NERVE PAIN RECEPTORS

    PENETRATING CREAM

    MEDICATED CREAM NET WT 3.0 OZ (85.1 g)

    318

  • INGREDIENTS AND APPEARANCE
    NERVIVE PAIN RELIEVING  CREAM
    lidocaine hcl and menthol cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84126-318
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE ANHYDROUS (UNII: EC2CNF7XFP) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS4 g  in 100 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER INTERPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 132584PQMO)  
    SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    C30-45 ALKYL CETEARYL DIMETHICONE CROSSPOLYMER (UNII: 4ZK9VP326R)  
    POLYOXYL 15 HYDROXYSTEARATE (UNII: 71YMM1X75O)  
    CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    STEARETH-21 (UNII: 53J3F32P58)  
    HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    CETETH-20 PHOSPHATE (UNII: 921FTA1500)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    ALCOHOL (UNII: 3K9958V90M)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84126-318-031 in 1 CARTON08/12/2024
    185.1 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01708/12/2024
    Labeler - The Procter & Gamble Manufacturing Company (004238200)
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