Label: THERABLAST MAXIMUM RELIEF- lidocaine, menthol lotion

  • NDC Code(s): 78663-201-34
  • Packager: Releaf Technologies LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 6, 2023

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  • ACTIVE INGREDIENT

    Lidocaine 4%
    Menthol 1%

  • PURPOSE

    TOPICAL ANALGESIC

  • USES

    For temporary relief of pain

  • WARNING

    For external use only.


    Do not use large quantities, particularly over raw surfaces or blistered areas.


    When using this product avoid contact with the eyes.


    Stop using and ask a doctor if

    • the condition worsens
    • symptoms persist for more than 7 days
    • symptoms clear up and occur again within a few days
    • a rash or irritation develops.
  • 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.

  • DIRECTIONS

    Adults and children 12 years of age and older: apply to the affected area not more than 3 to 4 times daily.
    Children under 12 years of age: do not use, ask a doctor.

  • OTHER INFORMATION

    Protect product from excessive moisture - Avoid storing in direct sunlight - Store with lid tightly closed

  • INACTIVE INGREDIENTS

    Purified water, Caprylic/Capric Triglycerides, Butyrospermum Parkii (Shea) butter, Cetearyl alcohol, polysorbate 60, Glyceryl stearate, Cyclopentasiloxane, Dimethicone, Phenoxyethanol, Ethylhexylglycerin, me, Extract of Aloe Barbadense leaves, Extract of arnica,
    Acrylamide/Sodium Acrylate Copolymer, Mineral Oil, Trideceth-6 Tocopheryl acetate, triethanol amine.

  • PRINCIPAL DISPLAY PANEL

    01b LBL_TheraBlast_100mL

  • INGREDIENTS AND APPEARANCE
    THERABLAST  MAXIMUM RELIEF
    lidocaine, menthol lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78663-201
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1 g  in 100 mL
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE4 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    TROLAMINE (UNII: 9O3K93S3TK)  
    TRIDECETH-6 (UNII: 3T5PCR2H0C)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    WATER (UNII: 059QF0KO0R)  
    HEMP (UNII: TD1MUT01Q7)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ARNICA MONTANA (UNII: O80TY208ZW)  
    ACRYLIC ACID/SODIUM ACRYLATE COPOLYMER (1:1; 600 MPA.S AT 0.2%) (UNII: M4PPW69Y4H)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78663-201-34100 mL in 1 TUBE; Type 0: Not a Combination Product11/06/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01711/06/2023
    Labeler - Releaf Technologies LLC (117532647)
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