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Cold and Hot Medicated by The Mentholatum Company

Medically reviewed on October 23, 2017

Dosage form: patch
Ingredients: MENTHOL 500mg
Labeler: The Mentholatum Company
NDC Code: 10742-1117

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.

Drug Facts

Active ingredient

Menthol 5%

Purpose

Menthol - Topical analgesic

Uses

temporarily relieves minor aches and pains of muscles and joints due to

arthritis
simple backache
strains
sprains
bursitis
tendonitis
bruises
cramps

Warnings

For external use only

When using this product
use only as directed
avoid contact with eyes or on mucous membranes
do not apply to wounds or to damaged or very sensitive skin
do not bandage tightly or use with a heating pad

Stop use and ask a doctor if
excessive redness or irritation is present
condition worsens
pain persist for more than 7 days
symptoms clear up and occur again within a few days

If pregnant or breast-feeding,

ask a health professional before use.

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 and over: apply patch to affected area as needed but not more than 4 times daily
children under 12 years: ask a doctor
for easy application; partially peel back protective film and apply exposed patch to site of pain. Carefully remove remaining film while pressing patch to skin.

Inactive ingredients

carbomer homopolymer, carboxymethylcellulose sodium, castor oil, dihydroxyaluminum aminoacetate, edetate disodium, glycerin, hydroxypropyl cellulose, kaolin, partially neutralized polyacrylate, polyvinyl alcohol, purified water, sorbitol solution, tartaric acid

Package/Label Principal Display Panel

Package/Label Principal Display Panel

Principal Display Panel

Principal Display Panel
COLD AND HOT MEDICATED 
menthol patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10742-1117
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL500 mg
Inactive Ingredients
Ingredient NameStrength
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) 
CARBOXYMETHYLCELLULOSE SODIUM 
CASTOR OIL 
DIHYDROXYALUMINUM AMINOACETATE 
EDETATE DISODIUM 
GLYCERIN 
POLYVINYL ALCOHOL 
POLYACRYLIC ACID (250000 MW) 
WATER 
SORBITOL 
TARTARIC ACID 
HYDROXYPROPYL CELLULOSE (TYPE E) 
Packaging
#Item CodePackage Description
1NDC:10742-1117-11 POUCH in 1 CARTON
15 PATCH in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34807/01/2014
COLD AND HOT MEDICATED 
menthol patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10742-1118
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL240 mg
Inactive Ingredients
Ingredient NameStrength
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) 
CARBOXYMETHYLCELLULOSE SODIUM 
CASTOR OIL 
DIHYDROXYALUMINUM AMINOACETATE 
EDETATE DISODIUM 
GLYCERIN 
POLYVINYL ALCOHOL 
POLYACRYLIC ACID (250000 MW) 
WATER 
SORBITOL 
TARTARIC ACID 
HYDROXYPROPYL CELLULOSE (TYPE E) 
Packaging
#Item CodePackage Description
1NDC:10742-1118-11 POUCH in 1 CARTON
15 PATCH in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34812/01/2014
Labeler - The Mentholatum Company (002105757)

 
The Mentholatum Company

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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