Label: CVS COLD AND HOT- menthol 16% 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 September 8, 2022

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  • ACTIVE INGREDIENT

    Menthol 16%

  • PURPOSE

    Topical analgesic

  • INDICATIONS & USAGE

    Temporarily alleviates minor aches and pains of muscles and joints associated with

    Arthritis

    Simple Backache

    Strains

    Bruises

    Cramps

  • WARNINGS

    For external use only

    Flammable:

    Do not use while smoking or near heat or flames. Avoid longterm storage above 104°F. Do not punctuate or incinerate. Contents under pressure. Do not store at temperatures above 120°F.

    When using this product use only as directed

    Read and follow all directions and warnings on this label

    Do not allow contact with 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

    Do not bandage or apply local heat (such as heating pads) or medicated patch to the area of use

    A transient burning sensation may occur upon application but generally disappears in several days

    If severe burning sensations occurs, discontinue use immediately

    Do not expose the area treated with product to heat or direct sunlight

    Avoid applying into skin folds

    Stop use and ask doctor if condition worsens, redness is present, irritation develops or symptoms persist for more than 7 days or clear up and occur again within few days. Do not use for longer than 1 week.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately (1-800-222-1222).

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

  • DOSAGE & ADMINISTRATION

    Directions:

    Shake well - adults and children 12 years of age and older: spray product on affected area, not more than 3 to 4 times daily.

    - children under 12 years of age: consult a doctor.

  • INACTIVE INGREDIENT

    Glycerin, Isobutane, Propylene Glycol, SD Alcohol 40B (29%), Water

  • PRINCIPAL DISPLAY PANEL

    Package Label

  • INGREDIENTS AND APPEARANCE
    CVS COLD AND HOT 
    menthol 16% spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51316-899
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL16 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOBUTANE (UNII: BXR49TP611)  
    DEHYDRATED ALCOHOL (UNII: 3K9958V90M)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51316-899-16113 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product09/08/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34809/08/2022
    Labeler - CVS (062312574)
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