Label: PAIN RELIEF- lidocaine, menthol cream

  • NDC Code(s): 72042-001-01, 72042-001-03
  • Packager: HUMN Pharmaceuticals Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 17, 2024

If you are a consumer or patient please visit this version.

View All Sections
  • ACTIVE INGREDIENT

    Active ingredients

    Lidocaine Hydrochloride 4.0% (w/w)

    Menthol 1.0% (w/w)

  • PURPOSE

    Purpose

    Anesthetic

    Analgesic, anesthetic, and antipruritic

  • INDICATIONS & USAGE

    Uses

    Temporary relief of:

    • pain

    • itching associated with:

    ▪ minor burns ▪ sunburn ▪ minor cuts ▪ scrapes ▪ insect bites ▪ minor skin irritations

  • WARNINGS

    Warnings

    For external use only.

  • DO NOT USE

    Do not use

    • in large quantities • over large areas of the body • over raw surfaces • over blistered areas

  • ASK DOCTOR

    Ask a doctor before use

    if child is under 2 years of age, and use only as directed

  • WHEN USING

    When using this product

    • avoid contact with eyes; if this happens, rinse thoroughly with water

  • STOP USE

    Stop use and ask a doctor

    • condition worsens • if symptoms persist for more than 7 days

    • clear up and occur again within a few days • you experience: pain, swelling, or blistering

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get

    medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions

    • adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily.

  • INFORMATION FOR PATIENTS

    Other information

    • do not use if seal is broken

    • store at 60-85° F

  • INACTIVE INGREDIENT

    Inactive ingredients

    Acrylates/Acrylamide Copolymer, Allantoin, Alpha-Lipoic Acid, Beeswax, Butylene Glycol, C12-15 Alkyl Benzoate, C13-14 Isoparaffin, Caprylic/Capric Triglyceride, Caprylyl Glycol, Ceteraryl Alcohol, Ceteth-20, Ceteth-10 Phosphate, Denatured Alcohol, Dicetyl Phosphate, Dimethicone, Glycerin, Glyceryl Stearate, Iodopropynyl Butylcarbamate, Isopropyl Myristate, Laureth-7, Lecithin, Mineral Oil, PEG-6 Stearate, PEG-100 Stearate, Phenoxyethanol, Polyacrylamide, Polysorbate 85, Purified Water, Steareth-2, Steareth-20, Steareth-21.

  • QUESTIONS

    Questions?

    1-866-335-3596 Monday to Friday 8 am to 6 pm EST .

  • PRINCIPAL DISPLAY PANEL

    TPR20 Pain Relief Label

    TPR Pain Relief Label

  • INGREDIENTS AND APPEARANCE
    PAIN RELIEF 
    lidocaine, menthol cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72042-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1 mg  in 100 mg
    LIDOCAINE HYDROCHLORIDE ANHYDROUS (UNII: EC2CNF7XFP) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS4 mg  in 100 mg
    Inactive Ingredients
    Ingredient NameStrength
    CETETH-20 (UNII: I835H2IHHX)  
    ALCOHOL (UNII: 3K9958V90M)  
    ALUMINUM DICETYL PHOSPHATE (UNII: WMV3R5DS7O)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PEG-6 STEARATE (UNII: 8LQC57C6B0)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)  
    STEARETH-2 (UNII: V56DFE46J5)  
    STEARETH-20 (UNII: L0Q8IK9E08)  
    CETETH-10 PHOSPHATE (UNII: 4E05O5N49G)  
    PEG-120 GLYCERYL STEARATE (UNII: 6941286E4I)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    LAURETH-7 (UNII: Z95S6G8201)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    DIMETHICONE 100 (UNII: RO266O364U)  
    POLYSORBATE 85 (UNII: A7F3N56197)  
    WATER (UNII: 059QF0KO0R)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE (UNII: FJ1H6M2JG9)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    ACRYLAMIDE (UNII: 20R035KLCI)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    ALLANTOIN (UNII: 344S277G0Z)  
    .ALPHA.-LIPOIC ACID (UNII: 73Y7P0K73Y)  
    STEARETH-21 (UNII: 53J3F32P58)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72042-001-011 in 1 CARTON05/19/2018
    170873.8 mg in 1 TUBE; Type 0: Not a Combination Product
    2NDC:72042-001-031 in 1 CARTON05/19/2018
    228349.5 mg in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01705/19/2018
    Labeler - HUMN Pharmaceuticals Inc (245630272)
    Registrant - Delta Pharma Inc (200161730)
    Establishment
    NameAddressID/FEIBusiness Operations
    Delta Pharma Inc.200161730manufacture(72042-001)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!