CARE ONE COOL HEAT EXTRA STRENGTH- menthol, methyl salicylate cream 
American Sales 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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American Sales Company Cool Heat Drug Facts

Active ingredient

Menthol 10%

Methyl salicylate 30%

Purpose

Topical analgesic

Uses

for the temporary relief of minor aches and pains of muscles and joints associated with:

•
arthritis
•
simple backache
•
strains
•
sprains
•
bruises

Warnings

For external use only

Do not use

•
other than as directed

When using this product

•
avoid contact with eyes and mucous membranes
•
do not bandage tightly or use with a heating pad
•
do not apply to wounds or damaged skin

Stop use and ask a doctor if

•
skin redness or excessive irritation of the skin develops
•
condition worsens or symptoms persist for more than 7 days
•
symptoms 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.

Directions

•
adults and children 12 years of age and older:
•
apply generously to painful muscles and joints
•
gently massage until it disappears
•
repeat as needed, 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)
•
Lot No. & Exp. Date, see crimp of tube and see box

Inactive ingredients

carbomer 940, 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 in Icy Hot®

Extra Strength

Cool Heat

Pain Relieving Cream

Arthritis, Backache, Sore Muscles, Body Aches

Cool Heat Carton

Cool Heat Carton

Cool Heat Carton

CARE ONE COOL HEAT  EXTRA STRENGTH
menthol, methyl salicylate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-692
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
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41520-692-851 in 1 CARTON06/20/200804/17/2013
135 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 finalpart34806/20/200804/17/2013
Labeler - American Sales Company (809183973)

Revised: 11/2017
Document Id: 94350870-f035-4fe9-ad0a-938fa117e8cb
Set id: 388822eb-6965-4b64-be1d-829346884493
Version: 2
Effective Time: 20171113
 
American Sales Company