Label: CVS COLD AND HOT- lidocaine, menthol patch

  • 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 May 11, 2018

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  • Active ingredients

    Lidocaine 4%

    Menthol 1%

  • Purpose

    Topical Anesthetic

    Topical Analgesic

  • Use

    For the temporary relief of pain.

  • Warnings

    For external use only

    Do not use

    • more than 1 patch on your body at a time 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 apply to wounds or damaged, broken or irritated skin
    • Do not allow contact with the eyes and mucous membranes
    • Do not bandage tightly or apply local heat (such as heating pads) to the area of use
    • Do not use at the same time as other topical analgesics
    • Dispose of used patch in manner that always keeps product away from children and pets. Used patches still contain the drug products that can produce serious adverse effects if a child or pet chews or ingests this patch

    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 physician before use.

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

  • Directions

    • Adults/children 12 years and older
    • clean and dry affected area
    • remove backing from patch by firmly grasping both ends and gently pulling until backing separates in middle
    • carefully remove smaller portion of backing from patch and apply exposed portion of patch to affected area
    • once exposed portion of patch is positioned, carefully remove remaining backing to completely apply patch to affected area
    • use 1 patch for up to 12 hours

    Children 12 years or younger: ask a doctor

  • Other information

    Store at room temperature – do not exceed 86º Fahrenheit, 30º Celsius.

  • Inactive ingredients

    Benzyl Alcohol, Carboxymethylcellulose Sodium, Dihydroxyaluminium Aminoacetate, Ethanol, Glycerin, Kaolin, Partially Neutralized Polyacrylate, Propylene Glycol, Polysorbate 80, Polyvinyl Pyrrolidone 90, Tartaric Acid , Tetrasodium Edetate, Titanium Dioxide, Urea, Water.

  • Principal Display Panel - Cold and Hot Patch Box Label

    NDC 66902-218-05

    MAXIMUM STRENGTH
    LIDOCAINE

    Cold & Hot
    Patch

    UP TO
    12
    HOURS

    MEDICATED PAIN RELIEF
    WITH MENTHOL

    LIDOCAINE 4%

    MENTHOL 1%

    • Desensitizes
      aggravated nerves
    • Easy to apply
    • Fast acting

    Topical Anesthetic

    Topical Analgesic

    Package Contains 5 individually
    wrapped Patches

    5 PATCHES

    3 5/16" x 5 1/2" (10 cm x 14 cm)

    Principal Display Panel - Cold and Hot Patch Box Label
  • Principal Display Panel - Cold and Hot Patch Label

    CVS
    Health™

    Compare to the active ingredients
    in IcyHot® Lidocaine Patch
    Plus Menthol*

    NDC 66902-218-05

    MAXIMUM STRENGTH
    LIDOCAINE

    Cold & Hot
    Patch

    MEDICATED PAIN RELIEF
    WITH MENTHOL

    LIDOCAINE 4%

    MENTHOL 1%

    • Desensitizes
      aggravated nerves
    • Easy to apply
    • Fast acting

    Topical Anesthetic

    Topical Analgesic

    1 PATCH

    3 5/16" x 5 1/2" (10 cm x 14 cm)

    Principal Display Panel - Cold and Hot Patch Label
  • INGREDIENTS AND APPEARANCE
    CVS COLD AND HOT 
    lidocaine, menthol patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66902-218
    Route of AdministrationTRANSDERMAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE40 mg
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL10 mg
    Inactive Ingredients
    Ingredient NameStrength
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)  
    ALCOHOL (UNII: 3K9958V90M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    KAOLIN (UNII: 24H4NWX5CO)  
    POLYACRYLIC ACID (8000 MW) (UNII: 73861X4K5F)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    POVIDONE K90 (UNII: RDH86HJV5Z)  
    TARTARIC ACID (UNII: W4888I119H)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    UREA (UNII: 8W8T17847W)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66902-218-055 in 1 BOX12/01/2017
    11 in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34812/01/2017
    Labeler - NATURAL ESSENTIALS, INC. (947484713)
    Establishment
    NameAddressID/FEIBusiness Operations
    NATURAL ESSENTIALS, INC.947484713MANUFACTURE(66902-218)
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