Label: TOPCARE PAIN RELIEVING ANALGESIC- lidocaine hydrochloride cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated January 27, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Lidocaine HCl 4%

  • Purpose

    Topical analgesic

  • Uses

    for the temporary relief of pain.

  • Warnings

    For external use only

    When using this product

    ♦
    avoid contact with eyes
    ♦
    do not apply to wounds or damaged skin
    ♦
    do not bandage tightly
    ♦
    do not use with heating pads or other heating devices
    ♦
    as with any drug, if you are pregnant or nursing a baby, seek the advice of a health professional before using this product
    ♦
    do not use in large quantities, particularly over raw surfaces or blistered areas

    Discontinue use and consult a doctor if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.

  • Directions

    ♦
    adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily
    ♦
    children under 12 years of age: do not use, consult a doctor
  • Other information

    store at room temperature

  • Inactive ingredients

    Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Alcohol denat., Aloe Barbadensis Leaf Juice, Aminomethyl Propanol, C30-45 Alkyl Cetearyl Dimethicone Crosspolymer, Caprylyl Methicone, Cetearyl Alcohol, Ceteth-20 Phosphate, Dicetyl Phosphate, Dimethicone, Disodium EDTA, Ethylhexylglycerin, Glyceryl Stearare SE, Phenoxyethanol, Steareth-21, Water.

  • Questions or comments?

    1-888-423-0139

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY
    TOPCO ASSOCIATES LLC
    ELK GROVE VILLAGE, IL 60007

  • PRINCIPAL DISPLAY PANEL - 77 g Bottle Carton

    NDC 36800-470-01

    TopCare
    health®

    COMPARE TO ASPERCREME® ODOR FREE WITH 4% LIDOCAINE ACTIVE INGREDIENT*

    ODOR FREE
    Pain Relieving Cream
    with Lidocaine HCl 4%
    MAXIMUM STRENGTH
    •Temporary Relief of Pain
    •Non-Greasy •Fast Acting •With Aloe

    NET WT 2.7 OZ (77 g)

    • OUR PHARMACISTS •
    RECOMMEND

    PRINCIPAL DISPLAY PANEL - 77 g Bottle Carton
  • INGREDIENTS AND APPEARANCE
    TOPCARE PAIN RELIEVING   ANALGESIC
    lidocaine hydrochloride cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-470
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS40 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    Alcohol (UNII: 3K9958V90M)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Aminomethylpropanol (UNII: LU49E6626Q)  
    Caprylyl Trisiloxane (UNII: Q95M2P1KJL)  
    Cetostearyl Alcohol (UNII: 2DMT128M1S)  
    Ceteth-20 Phosphate (UNII: 921FTA1500)  
    Dihexadecyl Phosphate (UNII: 2V6E5WN99N)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    Ethylhexylglycerin (UNII: 147D247K3P)  
    Glyceryl Stearate SE (UNII: FCZ5MH785I)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Steareth-21 (UNII: 53J3F32P58)  
    Water (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:36800-470-011 in 1 CARTON03/25/2020
    177 g in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34803/25/2020
    Labeler - Topco Associates LLC (006935977)
    Registrant - Garcoa, Inc. (036464697)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sigan Industries INC.255106239MANUFACTURE(36800-470)
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