Label: COOL N HEAT LIDOCAINE DRY- lidocaine and menthol, unspecified form spray

  • 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 March 8, 2021

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurposes
    Lidocaine 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 label
    • do not allow contact with the 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
    • avoid spraying on face
    • avoid inhalation of spray
    • do not bandage or apply local heat (such as heating pads) or a medicated patch to area of use
    • do not use at the same time as other topical analgesics
    • 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

    Extremely Flammable

    • do not use near heat or flame or while smoking
    • avoid long term storage above 104°F (40°C)
    • do not puncture or incinerate. Contents under pressure
    • do not store at temperatures above 120°F (49°C)

    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 :

    • spray affected area every 6 to 8 hours, not to exceed 3 applications in a 24 hour period
    • product will dry quickly on its own, and does not need to be rubbed in

    children 12 years or younger: ask a doctor

  • Inactive ingredients

    caprylic/capric triglyceride, isobutane, propylene glycol, SD alcohol 40B (30 %)

  • Questions or comments?

    1-888-577-8033

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELK GROVE VILLAGE, IL 60007

  • PRINCIPAL DISPLAY PANEL - 113 g Can Label

    NDC 36800-908-35

    TopCare
    health®

    COMPARE TO ICY HOT® LIDOCAINE PLUS
    MENTHOL DRY SPRAY ACTIVE INGREDIENTS*

    MAXIMUM STRENGTH

    Cool n' Heat
    Dry Spray
    Pain Relief
    with Lidocaine + Menthol

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

    •OUR PHARMACISTS•
    RECOMMEND

    CONTINUOUS SPRAY

    • Temporarily Numbs
      Pain Away
    • Dries Instantly
    • Non-Greasy

    ✓QUALITY
    GUARANTEED

    NET WT 4 OZ (113 g)

    Scan here for more
    information or
    call 1-888-423-0139

    PRINCIPAL DISPLAY PANEL - 113 g Can Label
  • INGREDIENTS AND APPEARANCE
    COOL N HEAT LIDOCAINE DRY 
    lidocaine and menthol, unspecified form spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-850
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE40 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
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    ISOBUTANE (UNII: BXR49TP611)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:36800-850-04113 g in 1 CAN; Type 0: Not a Combination Product05/01/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34805/01/2021
    Labeler - TOPCO ASSOCIATES LLC (006935977)