COOL HEAT- menthol and methyl salicylate cream
Kroger Company

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Active ingredient

Menthol 10%

Methyl salicylate 30%

Purpose

Topical analgesic

Uses

temporarily relieves minor pain associated with:

arthritis
simple backache
strains
sprains
bruises

Warnings

For external use only

When using this product

use only as directed
do not bandage tightly
do not use with a heating pad
avoid contact with the eyes or mucous membranes
do not apply to wounds or damaged or irritated skin

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

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions

adults and children over 12 years

apply generously to affected area
massage into painful area until thoroughly absorbed into skin
repeat as necessary, not more than 3 to 4 times daily

children 12 years or younger ask a doctor

Other information

store at 20°-25°C (68°-77°F)

Inactive ingredients

carbomer homopolymer type C, cetyl esters wax, emulsifying wax, oleth-3 phosphate, purified water, stearic acid, trolamine

Questions or comments?

1-800-632-6900

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Compare to the active ingredients of Icy Hot®

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extra strength

COOL HEAT

PAIN RELIEVING CREAM

Cold and Hot Therapy for Pain - Arthritis - Backache - Sore Muscles - Body Aches

Cool Heat Pain Relieving Cream Carton Image 1

Cool Heat Pain Relieving Cream Carton Image 2

COOL HEAT
menthol, methyl salicylate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:30142-692
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (MENTHOL)	MENTHOL	10 g in 100 g
METHYL SALICYLATE (METHYL SALICYLATE)	METHYL SALICYLATE	30 g in 100 g

Inactive Ingredients
Ingredient Name	Strength
CARBOMER HOMOPOLYMER TYPE C
CETYL ESTERS WAX
OLETH-3 PHOSPHATE
WATER
STEARIC ACID
TROLAMINE

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description
1	NDC:30142-692-85	1 in 1 CARTON
1		35 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	05/21/2010

Labeler - Kroger Company (006999528)

Revised: 12/2011

Document Id: 93c774b6-1549-4ef0-b07f-8f8ae1dfc23f

Set id: 93c774b6-1549-4ef0-b07f-8f8ae1dfc23f

Version: 1

Effective Time: 20111205

Kroger Company