EQUALINE COOL HEAT- menthol and methyl salicylate cream
Supervalu Inc

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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SuperValu Inc. Cool Heat Pain Relieving Cream Drug Facts

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?

1-877-932-7948

Principal Display Panel

compare to Icy Hot® active ingredients

extra strength

cold & heat therapy for pain

arthritis

backache

body aches

sore muscles

cool heat

pain relieving cream

Cool Heat Pain Relieving Cream Carton Image 1

Cool Heat Pain Relieving Cream Carton Image 2

EQUALINE COOL HEAT
menthol, methyl salicylate cream

Product Information
Product Type	HUMAN OTC DRUG LABEL	Item Code (Source)	NDC:41163-692
Route of Administration	TOPICAL	DEA Schedule

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

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description
Packaging
1	NDC:41163-692-85	1 in 1 CARTON
1		35 g in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	03/30/2010

Labeler - Supervalu Inc (006961411)

Revised: 12/2011

Document Id: 4e9ddf4d-5036-46bf-b542-621b7bcaaa2d

Set id: 4e9ddf4d-5036-46bf-b542-621b7bcaaa2d

Version: 1

Effective Time: 20111205

Supervalu Inc