CVS HEALTH COLD AND HOT ROLL-ON MENTHOL- menthol, unspecified form liquid

CVS Health Cold and Hot Roll-On by

Drug Labeling and Warnings

CVS Health Cold and Hot Roll-On by is a Otc medication manufactured, distributed, or labeled by NATURAL ESSENTIALS, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient:

Menthol 16%

Purpose:

Topical analgesic

Uses:

• temporarily relieves minor pain associated with:
  • arhtritis
  • simple backache
  • muscle strains
  • sprains
  • bruises
  • cramps

Warnings:

For external use only.

When using this product

• use only as directed. Read and follow all directions and warnings on this label.
• rare cases of serious burns have been reported with products of this type
• do not bandage tightly or apply local heat (such as heating pads) or medicated patch to the area of use
• avoid contact with eyes or mucous membranes
• do not apply to wounds or damaged, broken or irritated skin
• a transient burning sensation may occur upon application but generally disappears in several days
• if severe burning sensation 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 a doctor if

• condition worsens
• redness is present
• irritation develops
• symptoms persist for more than 7 days or clear up and occur again within a few days
• you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied.

Flammable

• Keep away from fire or flame.

If pregnant or breast-feeding,

• Ask a health professional before use.

Keep out of reach of children

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

Directions: adults and children over 12 years:

• apply a thin layer to affected area
• massage into painful area until thoroughly absorbed into skin
• repeat as necessary, but 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

Other information:

Store in a cool dry area. Close cap tightly after use.

Inactive Ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aminomethyl Propanol, Capsaicin, Deionized Water, Glycerin, Isopropyl Myristate, Propylene Glycol, SDA 40-2 Alcohol.

Principal Display Panel - Cold & Hot Roll-On Menthol 16% Box Label

CVS
Health™

Compare to the active
ingredient in Maximum
Strength IcyHot®
Pain Relieving Liquid

MAXIMUM STRENGTH

Cold & Hot
Roll-On

MENTHOL 16%

Pain-relieving liquid

• Long-lasting formula
• No-touch applicator
• Dries quickly

Actual Product Size
on Side Panel

2.5 FL OZ (73 mL)

Principal Display Panel - Cold & Hot Roll-On Menthol 16% Container Label

CVS
Health™

MAXIMUM STRENGTH

Cold & Hot
Roll-On

MENTHOL 16%

Pain-relieving liquid

• Long-lasting formula
• No-touch applicator
• Dries quickly

2.5 FL OZ (73 mL)

INGREDIENTS AND APPEARANCE

CVS HEALTH COLD AND HOT ROLL-ON   MENTHOL
menthol, unspecified form liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66902-241
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	160 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
CAPSAICIN (UNII: S07O44R1ZM)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ALCOHOL (UNII: 3K9958V90M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66902-241-25	1 in 1 BOX	01/17/2018
1		73 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 not final	part348	01/17/2018

Labeler - NATURAL ESSENTIALS, INC. (947484713)

Establishment
Name	Address	ID/FEI	Business Operations
NATURAL ESSENTIALS, INC.		947484713	MANUFACTURE(66902-241)