CVS MAXIMUM STRENGTH COLD AND HOT PAIN RELIEF TOPICAL ANALGESIC- menthol, unspecified form liquid

CVS Maximum Strength Cold and Hot Pain Relief by

Drug Labeling and Warnings

CVS Maximum Strength Cold and Hot Pain Relief by is a Otc medication manufactured, distributed, or labeled by CVS Health, Garcoa, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

Menthol 16.0%

Purpose

Topical Analgesic

Uses

for the temporary relief of minor aches and pain muscles and joints associated with:

• ♦ simple backache
• ♦ arthritis
• ♦ strains
• ♦ bruises and sprains
• ♦ cramps

Warnings

For external use only. Test on a small patch of skin before applying generously.

When using this product

• ♦ Use only as directed
• ♦ avoid contact with eyes
• ♦ do not apply to wounds or damages skin
• ♦ do not bandage tightly
• ♦ do not use with heating pads or other heating devices
• ♦ if redness is present, discontinue and consult a doctor
• ♦ if skin irritation occurs, discontinue use

Stop use and consult 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

Flammable

• ♦ keep away from fire or flame

If pregnant or breast-feeding, as 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 of age and older:

• ♦ apply generously to affected area
• ♦ massage into painful area until thoroughly absorbed into skin
• ♦ repeat if necessary, but not more than 3 to 4 times daily
• ♦ IF MEDICINE COMES IN CONTACT WITH HANDS, WASH WITH SOAP AND WATER

children under 12 years of age: ask a doctor

Inactive ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Alcohol Denat., Capsaicin, Citric Acid, Glycerin, Isopropyl Myristate, Propylene Glycol, Water.

SPL UNCLASSIFIED SECTION

Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895

PRINCIPAL DISPLAY PANEL - 73 mL Cylinder Carton

♥CVS
Health™

Compare to the active
ingredient in Icy Hot®*

MAXIMUM STRENGTH
Cold & Hot
PAIN RELIEF LIQUID

MENTHOL 16%

• No mess
• Strong, quick relief
• Roller ball applicator
  keeps hands clean
• Stain free & fast drying

Roll-on, easy
applicator

Actual Product Size
on Side Panel

2.5 FL OZ (73 mL)

INGREDIENTS AND APPEARANCE

CVS MAXIMUM STRENGTH COLD AND HOT PAIN RELIEF   TOPICAL ANALGESIC
menthol, unspecified form liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69842-374
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 Interpolymer Type A (Allyl Sucrose Crosslinked) (UNII: 59TL3WG5CO)
Alcohol (UNII: 3K9958V90M)
Capsaicin (UNII: S07O44R1ZM)
Citric Acid Monohydrate (UNII: 2968PHW8QP)
Glycerin (UNII: PDC6A3C0OX)
Isopropyl Myristate (UNII: 0RE8K4LNJS)
Propylene Glycol (UNII: 6DC9Q167V3)
Water (UNII: 059QF0KO0R)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69842-374-06	1 in 1 CARTON	01/01/2014
1	NDC: 69842-374-01	73 mL in 1 CYLINDER; 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	01/01/2014

Labeler - CVS Health (062312574)

Registrant - Garcoa, Inc. (036464697)

Establishment
Name	Address	ID/FEI	Business Operations
Garcoa, Inc.		036464697	MANUFACTURE(69842-374)