WALGREEN COOL N HEAT MAXIMUM STRENGTH PAIN RELIEVING- menthol, unspecified form liquid

Walgreen Cool n Heat Maximum Strength Pain Relieving by

Drug Labeling and Warnings

Walgreen Cool n Heat Maximum Strength Pain Relieving by is a Otc medication manufactured, distributed, or labeled by Walgreen Company, Garcoa, Inc., Sigan Industries INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

Menthol 16%

Purpose

Topical analgesic

Uses

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

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

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 the eyes and mucous membranes
• ♦ do not apply to wounds or damaged skin
• ♦ do not bandage tightly
• ♦ do not use with heating pads or other heating devices
• ♦ if redness is present, discontinue use and consult a doctor
• ♦ if skin irritation occurs, discontinue use
• ♦ a transient burning sensation may occur upon application but generally disappears in several days

Stop use and consult a doctor if

• ♦ condition worsens, or if 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, ask a health professional before use.

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

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 12 years or younger: ask a doctor before use.

Other information

store at room temperature

Inactive ingredients

acrylates/C10-30 alkyl acrylate crosspolymer, alcohol denat., capsaicin, citric acid, glycerin, isopropyl myristate, propylene glycol, water.

Questions or comments?

1-866-925-4733

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY: WALGREEN CO.
200 WILMOT RD., DEERFIELD, IL 60015

PRINCIPAL DISPLAY PANEL - 73 mL Bottle Carton

Walgreens

WALGREENS
PHARMACIST RECOMMENDED†

Compare to the active ingredient in
Maximum Strength Icy Hot®††

Cool 'n
Heat

16% MENTHOL /
PAIN RELIEVING LIQUID

Maximum Strength

Roll On
No Mess

• Pain relief therapy for
  arthritis, backache,
  muscle strains & sprains
• Fast-acting formula
• Roller ball applicator
  keeps hands clean
• Stain free & quick drying

NOT ACTUAL SIZE

2.5 FL OZ (73 mL)

INGREDIENTS AND APPEARANCE

WALGREEN COOL N HEAT MAXIMUM STRENGTH PAIN RELIEVING 
menthol, unspecified form liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0363-4837
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
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: 0363-4837-01	1 in 1 CARTON	01/09/2014
1		73 mL in 1 BOTTLE, WITH APPLICATOR; 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	01/09/2014

Labeler - Walgreen Company (008965063)

Registrant - Garcoa, Inc. (036464697)

Establishment
Name	Address	ID/FEI	Business Operations
Sigan Industries INC.		255106239	MANUFACTURE(0363-4837)