CVS COLD AND HOT- menthol 16% spray 
CVS

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.

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CVS cold and Hot Spray

Menthol 16%

Topical analgesic

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

Arthritis

Simple Backache

Strains

Bruises

Cramps

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

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

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.

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

Package Label

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)

Revised: 9/2022
Document Id: e82c9f84-4ae9-7989-e053-2a95a90a0c37
Set id: d1676df9-530f-1664-e053-2995a90a5b64
Version: 2
Effective Time: 20220908
 
CVS