Label: CVS HEALTH COLD AND HOT ROLL-ON- lidocaine, menthol cream

  • NDC Code(s): 66902-156-25
  • Packager: NATURAL ESSENTIALS, INC.
  • 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 June 1, 2023

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  • Active ingredients

    Lidocaine HCl 4%

    Menthol 1%

  • Purpose

    Topical anesthetic

    Topical analgesic

  • Uses

    temporarily relieves minor pain

  • Warnings

    For external use only

    • Avoid contact with eyes or mucous membranes
    • Do not apply to open wounds or damaged skin
    • Do not bandage or use heating pad

    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

    Stop use and ask a doctor if

    • Condition worsens
    • servere skin irritation occurs
    • Symptoms persist for more than 7 days or clear up then reoccur again within a few days

    Ask a doctor before use if you

    • Have sensitive skin
    • Are pregnant or breastfeeding
  • Keep out of reach of children.

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

  • Directions

    Rub on affected area - repeat 3 to 4 times daily

    • for adults and children 12 or over
    • under 12 consult doctor before use
  • Other information

    • This product may cause allergic reaction in some individuals. Test on small area before use.
  • Inactive ingredients

    Acrylates/C10-30 Alkyl Crosspolymer, Aloe Vera Gel 10x, Aminomethyl Propanol, Cetearyl Alcohol, Ceteth-20 Phosphate, Dicetyl Phosphate, Deionized Water, Dimethicone, Caprylyl Methicone, Polysilicone-11, Disodium EDTA, Ethylhexylglycerin, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Isohexadecane, Polysorbate 60, Methylparaben, SDA 40-2 Alcohol, Steareth-21

  • Principal Display Panel – 73.9 mL Carton Label

    CVS
    Health    ®

    Compare to active
    ingredients in IcyHot®
    Lidocaine Plus Menthol*

    MAXIMUM STRENGTH

    Lidocaine concentration
    without a prescription    ✝

    Lidocaine
    Pain Relief
    Roll-On

    PLUS MENTHOL

    LIDOCAINE HCl 4%

    MENTHOL 1%

    • Safe & effective
    • Fast acting & long lasting
    • Desensitizes
      aggravated nerves

    ✝Among over the counter
    topical analgesics.

    Actual Bottle Size
    on Side Panel

    2.5 FL OZ (73.9 mL)

    Principal Display Panel – 73.9 mL Carton Label
  • Principal Display Panel – 73.9 mL Container Label

    CVS
    Health    ®

    MAXIMUM STRENGTH

    Lidocaine concentration
    without a prescription    ✝

    Lidocaine
    Pain Relief
    Roll-On

    PLUS MENTHOL

    LIDOCAINE HCl 4%

    MENTHOL 1%

    • Safe & effective
    • Fast acting &
      long lasting
    • Desensitizes
      aggravated nerves

    2.5 FL OZ (73.9 mL)

    Principal Display Panel – 73.9 mL Container Label
  • INGREDIENTS AND APPEARANCE
    CVS HEALTH COLD AND HOT ROLL-ON  
    lidocaine, menthol cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66902-156
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 41 mg  in 1 mL
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 9 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETETH-20 PHOSPHATE (UNII: 921FTA1500)  
    DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)  
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    METHYLPARABEN SODIUM (UNII: CR6K9C2NHK)  
    ALCOHOL (UNII: 3K9958V90M)  
    STEARETH-21 (UNII: 53J3F32P58)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66902-156-251 in 1 BOX09/14/2018
    173.9 mL in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34809/14/2018
    Labeler - NATURAL ESSENTIALS, INC. (947484713)
    Establishment
    NameAddressID/FEIBusiness Operations
    NATURAL ESSENTIALS, INC.947484713MANUFACTURE(66902-156)
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