Perrigo Company Cool Heat Drug Facts

Exchange Select Cool Heat by

Drug Labeling and Warnings

Exchange Select Cool Heat by is a Otc medication manufactured, distributed, or labeled by Army & Air Force Exchange Service. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

EXCHANGE SELECT COOL HEAT- menthol, methyl salicylate cream 
Army & Air Force Exchange Service

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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Perrigo Company Cool Heat Drug Facts

Active ingredients

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?

1-800-719-9260

Principal Display Panel

Compare to the active ingredients of Icy Hot® Cream

COLD & HOT THERAPY FOR PAIN

Arthritis

Body Aches

Back Aches

Sore Muscles

EXTRA STRENGTH

Cool Heat

pain relieving CREAM

NET WT 3 oz (85 g)

Exchange Select Cool Heat image
EXCHANGE SELECT COOL HEAT 
menthol, methyl salicylate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 55301-692
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL10 g  in 100 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE30 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CETYL ESTERS WAX (UNII: D072FFP9GU)  
OLETH-3 PHOSPHATE (UNII: 8Q0Z18J1VL)  
WATER (UNII: 059QF0KO0R)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TROLAMINE (UNII: 9O3K93S3TK)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 55301-692-211 in 1 CARTON05/23/201602/13/2018
185 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34805/23/201602/13/2018
Labeler - Army & Air Force Exchange Service (001695568)

Revised: 11/2019
Document Id: 33129c30-746c-4c31-9a23-2c7000860a69
Set id: b88f3b1b-9c52-4695-8ee1-958981346238
Version: 2
Effective Time: 20191108
 
Army & Air Force Exchange Service