Your browser does not support JavaScript! COOL HEAT (MENTHOL, METHYL SALICYLATE) CREAM [SAFEWAY]
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RxNorm Names

COOL HEAT (menthol, methyl salicylate) cream
[Safeway]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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.
Drug Label Sections

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
symptoms persist for more than 7 days or clear up and occur again within a few days
redness is present
irritation develops

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, cetyl esters wax, emulsifying wax, oleth-3 phosphate, purified water, stearic acid, trolamine

Questions or comments?

1-888-SAFEWAY

Principal Display Panel

Extra Strength

Compare to Icy Hot® Cream active ingredients

Cool Heat

Pain Relieving Cream

Cold & Hot Therapy for Pain

NET WT 3 OZ (85 g)

Safeway Cool Heat 1.jpg
Safeway Cool Heat 2.jpg
COOL HEAT 
menthol, methyl salicylate cream
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:21130-692
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL10 g  in 100 g
METHYL SALICYLATE (SALICYLIC ACID) METHYL SALICYLATE30 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CETYL ESTERS WAX 
OLETH-3 PHOSPHATE 
WATER 
STEARIC ACID 
TROLAMINE 
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:21130-692-601 in 1 CARTON
185 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34810/15/2013
Labeler - Safeway (009137209)

Revised: 11/2013
 
Safeway

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