CVS COLD AND HOT ROLL-ON- cool and heat pain relief liquid

CVS Cold and Hot Roll-On by

Drug Labeling and Warnings

CVS Cold and Hot Roll-On by is a Otc medication manufactured, distributed, or labeled by CVS Pharmacy, Pharma Nobis, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DOSAGE & ADMINISTRATION

Adults and children over 12 yrs of age: apply to the affected area no more than 3 to 4 times daily

IF MEDICINE COMES IN CONTACT WITH HANDS, WASH WITH SOAP AND WATER.

Children 12 years or younger: ask a doctor.

WARNINGS

When using this product: use only as directed. Do not bandage tightly or use with a heating pad. Avoid contact with eyes and mucous membranes. Do not apply to wounds or damaged, broken or irritated skin. A temporary burning sensation may occur after use but normally disappears in several days. If severe burning sensation occurs, discontinue use immediately. If swelling or blistering of the skin occurs, stop use and seek medical attention. Do not expose treated area to heat or direct sunlight.

INACTIVE INGREDIENT

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Capsaicin, Glycerin, Isopropyl Myristate, Propylene Glycol, SD Alcohol 40 (30%Z), Triethanolamine, Purified Water.

INDICATIONS & USAGE

Temporarily relieves minor muscle and joint pain associated with arthritis, simple backache, muscle strains, sprains, bruises.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

PURPOSE

Topical analgesic

ACTIVE INGREDIENT

Menthol 16%

PREGNANCY OR BREAST FEEDING

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CVS COLD AND HOT ROLL-ON 
cool and heat pain relief liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69842-399
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
(C10-C30)ALKYL METHACRYLATE ESTER (UNII: XH2FQZ38D8)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
TROLAMINE (UNII: 9O3K93S3TK)
ALCOHOL (UNII: 3K9958V90M)
CAPSAICIN (UNII: S07O44R1ZM)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69842-399-97	1 in 1 CARTON	01/13/2021
1		74 mL in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	01/13/2021

Labeler - CVS Pharmacy (062312574)

Registrant - Pharma Nobis, LLC (118564114)

Establishment
Name	Address	ID/FEI	Business Operations
Pharma Nobis, LLC		118564114	pack(69842-399) , analysis(69842-399) , manufacture(69842-399) , label(69842-399)