CVS HEALTH COLD AND HOT PAIN RELIEVING EXTRA STRENGTH- menthol, methyl salicylate cream

CVS Health Cold and Hot Pain Relieving by

Drug Labeling and Warnings

CVS Health Cold and Hot Pain Relieving by is a Otc medication manufactured, distributed, or labeled by CVS Pharmacy. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Menthol 10%

Methyl salicylate 30%

Purpose

Menthol - Topical analgesic

Methyl salicylate - Topical analgesic

Uses

temporarily relieves minor aches and pains of muscles and joints associated with:

• simple backache
• arthritis
• muscle strains
• muscle sprains
• bruises

Warnings

For external use only

When using this product

• use only as directed
• do not get into eyes or on mucous membranes
• do not apply to wounds or irritated or damaged skin
• do not bandage tightly
• do not use with a heating pad or apply external heat

Stop use and ask a doctor if

• skin redness or excessive irritation of the skin occurs
• condition worsens
• symptoms persist for more than 7 days or clear up and occur again within a few days

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 12 years and over: apply to affected area not more than 3 to 4 times daily
• children under 12 years: ask a doctor

Inactive Ingredients

glyceryl stearate, isoceteth-20, poloxamer 407, purified water, sodium lauryl sulfate, sorbitan monostearate

Principal Display Panel

INGREDIENTS AND APPEARANCE

CVS HEALTH COLD AND HOT PAIN RELIEVING  EXTRA STRENGTH
menthol, methyl salicylate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59779-791
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	100 mg  in 1 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	300 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
ISOCETETH-20 (UNII: O020065R7Z)
POLOXAMER 407 (UNII: TUF2IVW3M2)
WATER (UNII: 059QF0KO0R)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59779-791-01	1 in 1 CARTON	10/03/2016
1		85 g in 1 TUBE; 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	10/03/2016

Labeler - CVS Pharmacy (062312574)