Label: LIDOCAINE PLANTAR FASCIITIS HEEL PAIN RELIEF CREAM- 4% lidocaine, 1% menthol cream

  • NDC Code(s): 84165-101-01, 84165-101-02
  • Packager: Guangzhou Zhupuyou E-commerce Co., Ltd
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated March 8, 2024

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  • SPL UNCLASSIFIED SECTION

    LIDOCAINE PLANTAR FASCIITIS Heel Pain Relief Cream

  • ACTIVE INGREDIENT

    4% LIDOCAINE, 1% Menthol

  • PURPOSE

  • PURPOSE

    Topical anesthetic

  • INDICATIONS & USAGE

    Temporarily relieves muscle soreness and minor joint pains in the wrist, knees, back, neck, hips, shoulders, elbows.

  • WARNINGS

    For external use only

  • DO NOT USE

    On wounds or damaged skin.
    With a heating pad or device.
    With other ointments, creams, sprays, or liniments.
    If you are allergic to any ingredients of this product.

  • WHEN USING

    Use only as directed
    Avoid contact with the eyes, mucous membranes, or rashes
    Do not bandage tightly

  • STOP USE

    skin reactions such as redness, swelling, blistering or other discomfort occur.
    symptoms persist for more than 7 days.

  • KEEP OUT OF REACH OF CHILDREN

    If swalkowed accidentally , get medical help or contact with Poison Control Center immediately.

  • DOSAGE & ADMINISTRATION

    Children under 12: Consult a doctor.
    Adults and children 12 years and older: For optimum results cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting withl toilet tissue or a clean, soft cloth before application of this product.

  • STORAGE AND HANDLING

    Store indoors in a cool and shady place

  • INACTIVE INGREDIENT

    Water
    Paraffinum Liquidum
    Glycerin
    Cetearyl Alcohol
    Glyceryl Stearate
    Polysorbate 60
    Peg-100 Stearate
    Polyacrylamide
    Phenoxyethanol
    Allantoin
    Carbomer
    Phryma Leptostachya Extract
    Zingiber Officinale (Ginger) Root Extract
    Angelica Sinensis Extract
    Panax Ginseng Extract
    Ligusticum Chuanxiong Extract
    Triethanolamine
    Methylparaben
    C13-14 Isoparaffin
    Laureth-7
    Disodium Edta

  • PRINCIPAL DISPLAY PANEL

    labellabel2

  • INGREDIENTS AND APPEARANCE
    LIDOCAINE PLANTAR FASCIITIS HEEL PAIN RELIEF CREAM 
    4% lidocaine, 1% menthol cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84165-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LEVOMENTHOL (UNII: BZ1R15MTK7) (LEVOMENTHOL - UNII:BZ1R15MTK7) LEVOMENTHOL1 g  in 100 g
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE4 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    PARAFFIN (UNII: I9O0E3H2ZE)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    PHRYMA LEPTOSTACHYA WHOLE (UNII: 6G287VJM69)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    ANGELICA SINENSIS ROOT (UNII: B66F4574UG)  
    LIGUSTRAZINE (UNII: V80F4IA5XG)  
    GINGER (UNII: C5529G5JPQ)  
    GLYCERYL 1-STEARATE (UNII: 258491E1RZ)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    LAURETH-7 CARBOXYLIC ACID (UNII: 3180MRU2VG)  
    CETYL ACETATE (UNII: 4Q43814HXS)  
    POLYACRYLAMIDE (1500 MW) (UNII: 5D6TC4BRWV)  
    ALLANTOIN (UNII: 344S277G0Z)  
    PANAXYNOL (UNII: 8P1DJD416I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84165-101-0160 g in 1 BOTTLE; Type 0: Not a Combination Product03/08/2024
    2NDC:84165-101-02114 g in 1 BOTTLE; Type 0: Not a Combination Product03/08/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01703/08/2024
    Labeler - Guangzhou Zhupuyou E-commerce Co., Ltd (418214143)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guangzhou Zhupuyou E-commerce Co., Ltd418214143manufacture(84165-101)
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