CVS COLD AND HOT- menthol 16% spray

CVS cold and Hot by

Drug Labeling and Warnings

CVS cold and Hot by is a Otc medication manufactured, distributed, or labeled by CVS. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

CVS COLD AND HOT 
menthol 16% spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51316-899
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	16 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
ISOBUTANE (UNII: BXR49TP611)
DEHYDRATED ALCOHOL (UNII: 3K9958V90M)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51316-899-16	113 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	09/08/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	09/08/2022

Labeler - CVS (062312574)