COOL HEAT- menthol and methyl salicylate cream 
Rite Aid Corporation

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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Rite Aid Corporation Cool Heat 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
  • 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 type C, cetyl esters wax, emulsifying wax, oleth-3 phosphate, purified water, stearic acid, trolamine

Questions or comments?

1-800-719-9260

Principal Display Panel

Compare to the active ingredients of Icy Hot®

Cold & Hot Therapy for pain

Arthritis

Backaches

Sore Muscles

Body Aches

Extra Strength

Cool Heat

Pain Relieving Cream

Cool Heat Carton Image 1

Cool Heat Carton Image 1

Cool Heat Carton Image 2

Cool Heat Carton Image 2

COOL HEAT 
menthol, methyl salicylate cream
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:11822-0692
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL10 g  in 100 g
METHYL SALICYLATE (METHYL SALICYLATE) METHYL SALICYLATE30 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CETYL ESTERS WAX 
OLETH-3 PHOSPHATE 
WATER 
STEARIC ACID 
TROLAMINE 
CARBOMER HOMOPOLYMER TYPE C 
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11822-0692-11 in 1 CARTON
185 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34807/26/2005
Labeler - Rite Aid Corporation (014578892)

Revised: 11/2011
Document Id: 5b6bedf8-9918-4e2d-b00f-4d08f101ac01
Set id: 5b6bedf8-9918-4e2d-b00f-4d08f101ac01
Version: 1
Effective Time: 20111129
 
Rite Aid Corporation