SOLE SERUM (LIDOCAINE) SPRAY [THE COMFORT LAB LLC]

SOLE SERUM (LIDOCAINE) SPRAY [THE COMFORT LAB LLC]
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NDC 61867-101-11, 61867-101-12, 61867-101-51, 61867-101-52
Set ID 3d855db4-b10f-474b-88fc-fdade8a8226e
Category HUMAN OTC DRUG LABEL
Packager THE COMFORT LAB LLC
Generic Name
Product Class Amide Local Anesthetic, Antiarrhythmic
Product Number
Application Number PART348
  • ACTIVE INGREDIENT

    Active Ingredient

    Lidocaine Hydrochloride 4%

  • PURPOSE

    Purpose
    External Analgesic

  • INDICATIONS & USAGE

    Use
    For temporary relief of minor aches and pains of
    muscles and joints.

  • WARNINGS

    Warnings
    For external use only. If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a physician. Do not use in large quantities, particularly over raw surfaces or blistered areas. Avoid contact with the eyes. Rinse with water to remove.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN.

  • DOSAGE & ADMINISTRATION

    Directions
    Apply 2 pumps to foot where pain is felt. Apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: consult a physician.

  • INACTIVE INGREDIENT

    Inactive Ingredients
    Acrylates/C10-30 Alkyl Acrylates Crosspolymer, Acrylates/Dimethicone Copolymer, Alkyl Benzoate, Diazolidinyl Urea, Ethoxydiglycol, Ethylenediaminetetraacetic acid, Disodium EDTA, Ethylhexyl Palmitate, Glyceryl Stearate, Peg 100 Stearate, Isododecane, Behenyl
    Methacrylate/t-Butyl Methacrylate Copolymer, Isopropyl Palmitate, Lavandula Angustifolia (Lavender) Oil, Lecithin, Malaleuca Alternifolia {Tea
    Tree) Leaf Oil, Mentha Piperita (Peppermint) Oil, Menthol, Peg-8 Dimethicone, Phenoxyethanol,Benzoic Acid, Ethylhexylglycerin, Glycereth -2 Cocoate, Poloxamer 407, Potassium Cetyl Phosphate, Potassium Sorbate, Propylene Glycol, Sorbic Acid, Water

  • OTHER SAFETY INFORMATION

    Other Information
    Provides penetrating foot pain relief

  • PRINCIPAL DISPLAY PANEL

    15ML BOTTLE ART

    sole serum_15 ml box art

  • INGREDIENTS AND APPEARANCE
    SOLE SERUM 
    lidocaine spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61867-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE4 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
    EDETIC ACID (UNII: 9G34HU7RV0)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    Ethylhexyl Palmitate (UNII: 2865993309)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    ISODODECANE (UNII: A8289P68Y2)  
    TERT-BUTYL METHACRYLATE (UNII: F9029V5818)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    MENTHOL (UNII: L7T10EIP3A)  
    PEG-8 DIMETHICONE (UNII: GIA7T764OD)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLYCERETH-2 COCOATE (UNII: JWM00VS7HC)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SORBIC ACID (UNII: X045WJ989B)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61867-101-511 in 1 BOX
    1NDC:61867-101-1115 mL in 1 BOTTLE
    2NDC:61867-101-521 in 1 BOX
    2NDC:61867-101-1230 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34802/24/2014
    Labeler - THE COMFORT LAB LLC (079250438)
    Registrant - THE COMFORT LAB LLC (079250438)

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