Label: TOPCARE COLD AND HOT PAIN RELIEVING ANALGESIC- lidocaine hydrochloride and menthol, unspecified form 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 August 2, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    Lidocaine HCl 4%Topical analgesic
    Menthol 1%Topical analgesic
  • Use

    temporarily relieves minor pain

  • Warnings

    For external use only

    Do not use

    ◆
    on large areas of the body or on cut, irritated or swollen skin
    ◆
    on puncture wounds
    ◆
    for more than one week without consulting a doctor

    When using this product

    ◆
    use only as directed. Read and follow all directions and warnings on this carton
    ◆
    rare cases of serious burns have been reported with products of this type
    ◆
    do not bandage or apply local heat (such as heating pads) to the area of use with a medicated patch
    ◆
    avoid contact with eyes and mucous membranes
    ◆
    a transient burning sensation may occur upon application but generally disappears in several days

    Discontinue use and consult a doctor if

    ◆
    condition worsens
    ◆
    redness is present
    ◆
    irritation develops
    ◆
    symptoms persist for more than 7 days or clear up and occur again within a few days
    ◆
    you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied

    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 (1-800-222-1222) immediately.

  • Directions

    Adults and children over 12 years:

    ◆
    Apply to affected area not more than 3 to 4 times daily
    ◆
    AFTER APPLYING, WASH HANDS WITH SOAP AND WATER

    children under 12 years or younger: ask 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 stearate, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, isohexadecane, phenoxyethanol, polysorbate 60, 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

    TopCare®
    health

    COMPARE TO ICY HOT® ACTIVE INGREDIENTS*

    MAXIMUM STRENGTH LIDOCAINE

    Cold & Hot
    Pain Relieving
    Lidocaine Cream

    4% Lidocaine • 1% Menthol

    LIDOCAINE 4% / TOPICAL ANALGESIC
    MENTHOL 1% / TOPICAL ANALGESIC

    • Helps to Numb Away Pain
    • Non-Greasy
    • Maximum Strength External
      Analgesic with 4% Lidocaine

    NET WT 2.7 OZ (77 g)

    PRINCIPAL DISPLAY PANEL - 77 g Bottle Carton
  • INGREDIENTS AND APPEARANCE
    TOPCARE COLD AND HOT PAIN RELIEVING   ANALGESIC
    lidocaine hydrochloride and menthol, unspecified form cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76162-180
    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
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM10 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)  
    C30-45 Alkyl Cetearyl Dimethicone Crosspolymer (UNII: 4ZK9VP326R)  
    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 MONOSTEARATE (UNII: 230OU9XXE4)  
    HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)  
    Isohexadecane (UNII: 918X1OUF1E)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Polysorbate 60 (UNII: CAL22UVI4M)  
    Steareth-21 (UNII: 53J3F32P58)  
    Water (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76162-180-011 in 1 CARTON05/24/2022
    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 FINALpart34805/24/2022
    Labeler - Topco Associates, LLC (006935977)
    Registrant - Garcoa, Inc. (036464697)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sigan Industries INC.255106239MANUFACTURE(76162-180)
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