Label: MAXIMUM STRENGTH COLD AND HOT CVS- lidocaine hci 4% menthol 1% 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 April 26, 2018

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  • Active ingredients                            Purpose

    Lidocaine HCL 4%............................Topical analgesic

    Menthol  1%.....................................Topical analgesic

  • PURPOSE

  • Uses

    Temporarily relieves pain and itching due to:
    • sunburn • minor burns • minor cuts • scrapes • insect bites

  • WarningsFor external use only

    Do not use • in large quantities, particularly over raw surface or blistered areas

    When using this product

    •avoid contact with eyes

    • do not apply to wounds or damages skin
    • do not bandage tightly or use with a heating pad
    • use only as directed

    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

    Keep out of reach of the children
    If product is swallowed, get medical help or contact a Poison Control Center right away

  • Directions

    • adults and children 12 years of age and older: spray on affected area, not more than 3 to 4 times daily
    • children under 12 years of age: consult a doctor

  • Inactive ingredients

    Acrylates/C10-30 Alkyl Acrylate Crosspolymer
    Aloe Barbadensis Leaf Extract
    Aminomethyl Propanol
    C30-45 Alkyl Cetearyl Dimethicone Crosspolymer
    Caprylyl Methicone
    Cetearyl Alcohol
    Ceteth-20 Phosphate
    Dicetyl Phosphate
    Dimethicone
    Disodium EDTA
    Ethylhexylglycerin
    Glyceryl Stearate SE
    Hydroxyethyl Acrylate/Sodium Acryloydimethyl Taurate Copolymer
    Isohexadecane
    Methylparaben
    Polysorbate 60
    SD Alcohol 40
    Steareth-21
    Water

  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    MAXIMUM STRENGTH COLD AND HOT  CVS
    lidocaine hci 4% menthol 1% cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-667
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS4 g  in 100 mL
    Menthol (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) Menthol1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    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)  
    Isohexadecane (UNII: 918X1OUF1E)  
    Methylparaben (UNII: A2I8C7HI9T)  
    Polysorbate 60 (UNII: CAL22UVI4M)  
    ALCOHOL (UNII: 3K9958V90M)  
    Steareth-21 (UNII: 53J3F32P58)  
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69842-667-031 in 1 CARTON01/30/2018
    180 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34801/30/2018
    Labeler - CVS (062312574)
    Registrant - Product Quest Mfg (927768135)
    Establishment
    NameAddressID/FEIBusiness Operations
    Product Quest Mfg927768135manufacture(69842-667) , label(69842-667)
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