Label: ICY HOT WITH LIDOCAINE NO-MESS- menthol and lidocaine liquid

  • 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 November 20, 2022

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    ICY HOT with LIDOCAINE NO MESS

    Drug Facts

  • Active ingredients

    Lidocaine HCL

    Menthol

  • Purposes

    Lidocaine HCl 4%............................................................................................................................Topical anesthetic

    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.

    ■ avoid contact with eyes and mucous membranes

     rare cases of serious burns have been reported with products of this type

    ■ do not apply to wounds or damaged, broken or irritated skin

    ■ do not bandage tightly or apply local heat (such as heating pads) or a medicated patch to the area of use

    ■ a transient burning sensation may occur upon application but generally disappears in several days

     avoid applying into skin folds

    Stop use and ask 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 right away.

  • Directions

    adults and children over 12 years:

    ■ apply a thin layer to affected area not more than 3 to 4 times daily

    ■ massage into painful area until thoroughly absorbed into skin

    IF MEDICINE COMES IN CONTACT WITH HANDS, WASH WITH SOAP AND WATER

    children 12 years or younger: ask a doctor

  • Inactive ingredients

    2-amino-2methylpropanol, acrylates/C10-30 alkyl acrylate crosspolymer, aloe vera juice, caprylyl methicone, cetearyl alcohol, cetyl alcohol, ceteth-10 phosphate, dicetyl phosphate, dimethicone, disodium EDTA, ethylhexylglycerin, isopropyl alcohol, phenoxyethanol, polysorbate 60, purified water, stearyl alcohol

  • PRINCIPAL DISPLAY PANEL

    1

  • INGREDIENTS AND APPEARANCE
    ICY HOT WITH LIDOCAINE NO-MESS 
    menthol and lidocaine liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-3788
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE4 g  in 100 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    CETETH-10 PHOSPHATE (UNII: 4E05O5N49G)  
    CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11822-3788-970.8 g in 1 BOTTLE; Type 0: Not a Combination Product09/30/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34809/30/2020
    Labeler - Rite Aid Hdgrts Corp (014578892)
    Registrant - Velocity Pharma LLC (962198409)