Label: PHARMAPURERX MENTHOTRAL- lidocaine, menthol cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated March 5, 2019

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  • Active ingredients (% w/w)

    Lidocaine 3.88%

    Menthol 3%

  • Purposes

    Topical Anesthetic (Lidocaine 3.88%)
    Topical Analgesic (Menthol 3%)

  • Uses

    for the temporary relief of minor pain, itching and irritation due to / associated with
    ■ simple backache   ■ arthritis   ■ sprains   ■ muscle strains   ■ bruises
    ■ minor cuts/scrapes   ■ minor burns/sunburn   ■ insect bites

  • Warnings

    For external use only

    Do not use

    ■ if allergic to lidocaine or any other local anesthetics
    ■ over a large skin area   ■ on deep puncture wounds   ■ on infections
    ■ on raw surfaces or blistered areas

    When using this product

    ■ do not get into eyes   ■ do not use in large quantities
    ■ do not bandage or apply heat to treated areas
    ■ wash hands immediately after using

    Stop use and ask a doctor if

    ■ condition worsens
    ■ symptoms last more than 7 days or clear up and occur again within a few days

    If pregnant or breast-feeding,

    ask a health professional before use.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    ■ Adults and children over 12 years of age: apply a thin layer to the affected area up to 3 to 4 times a day
    ■ Children 12 years of age or younger: consult a doctor

  • Other information

    ■ keep container tightly closed   ■ store at 20° to 25°C (68° to 77°F)

  • Inactive ingredients

    Aminomethyl Propanol, Carbomer, Ceteareth-20, Cetyl Ethylhexanoate, Cetyl Phosphate, Diisobutyl Adipate, Disodium EDTA, Fragrance, Glycerin, Glyceryl Stearate SE, Phenoxyethanol, Purified Water, Stearic Acid.

  • PRINCIPAL DISPLAY PANEL

    PharmapureRx® Menthotral™ Cream (Lidocaine 3.88% / Menthol 3%)

    Topical Use Only

    Manufactured in the USA by:
    PureTek Corporation
    San Fernando, CA 91340
    877-921-7873

    image description

  • INGREDIENTS AND APPEARANCE
    PHARMAPURERX MENTHOTRAL 
    lidocaine, menthol cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59088-587
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE ANHYDROUS (UNII: EC2CNF7XFP) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS38.8 mg  in 1 mL
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL30 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    CETYL ETHYLHEXANOATE (UNII: 134647WMX4)  
    CETYL PHOSPHATE (UNII: VT07D6X67O)  
    DIISOBUTYL ADIPATE (UNII: 8OPY05ZY7S)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    WATER (UNII: 059QF0KO0R)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59088-587-16237 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/03/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other08/03/2017
    Labeler - PureTek Corporation (785961046)
    Establishment
    NameAddressID/FEIBusiness Operations
    PureTek Corporation785961046manufacture(59088-587)
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