Label: COLD AND HOT NO MESS MEDICATED- 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 October 6, 2020

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  • Active ingredient

    Menthol 16%

  • Purpose

    Topical analgesic

  • Uses

    • relieves minor pain of muscles and joints associated with:
      • arthritis
      • simple backache
      • strains
      • bruises
      • sprains
  • Warnings

    For external use only

    Flammable:

    • Do not use while smoking or near heat or flame

    Do not apply

    • to wounds or damaged, broken or irritated skin.
    • Do not allow contact with eyes or mucous membranes.

    When using this product

    • keep out of eyes
    • do not bandage tightly
    • do not use with a heating pad
    • use only as directed
    • do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120ºF.

    Stop use and ask a doctor if

    • condition worsens
    • symptoms persist for more than 7 days or clear up and occur again within a few days
    • needed for longer than a week

    If pregnant or breast-feeding,

    • ask a health professional before use.

    Keep out of reach of children and pets.

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

    • shake well
    • adults and children 12 years of age and older:
    • spray product on area not more than 1 to 3 times daily
    • children under 12 years of age
    • ask a doctor
  • Other information

    • May cause staining. Use with caution when spraying near fabric and unprotected surfaces
  • Inactive ingredients

    Glycerin, Propylene Glycol, SDA 40-2 Alcohol, Water.

  • Principal Display Panel - 4 oz Can Label

    CVS
    Health    ™

    Compare to the
    active ingredient in
    IcyHot® Pain Relief Spray*

    Cold & Hot

    MENTHOL 16%

    No Mess Medicated Spray

    Topical analgesic

    SPRAYS AT
    ANY ANGLE

    • Pain relief therapy
      for arthritis, backache,
      muscle strains
      & sprains
    • Non-greasy
    • Quick drying

    NET WT 4 0Z (113 g)

    Figure
  • INGREDIENTS AND APPEARANCE
    COLD AND HOT NO MESS MEDICATED 
    menthol, unspecified form spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66902-856
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM160 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66902-856-04118 g in 1 CAN; Type 0: Not a Combination Product10/06/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34810/06/2020
    Labeler - Natural Essentials, Inc. (947484713)
    Establishment
    NameAddressID/FEIBusiness Operations
    NATURAL ESSENTIALS, INC.947484713MANUFACTURE(66902-856)
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