COLD AND HOT MEDICATED- menthol patch 
The Mentholatum 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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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

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; grasp both ends of pad firmly, pull at both ends. Stretch pad until the backing separates. Remove protective film while applying pad directly to site of pain.

Inactive ingredients

carboxymethylcellulose sodium, dihydroxyaluminum aminoacetate, edetate disodium, glycerin, isopropyl myristate, partially hydrolyzed polyvinyl alcohol, partially neutralized polyacrylates, polyacrylic acid, polysorbate 80, purified water, sodium polyacrylate starch, sorbeth-60 tetraoleate, sorbitan sesquioleate, sorbitol solution, talc, tartaric acid

Package/Label Principal Display Panel

Cold and Hot Medicated Patch Menthol 5% (Large)

Cold and Hot Medicated Patch Menthol 5% Large

Package/Label Principal Display Panel

Cold and Hot Medicated Patch Menthol 5% (Small)

Cold and Hot Medicated Patch Menthol 5% Small
COLD AND HOT MEDICATED 
menthol patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10742-8117
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM50 mg
Inactive Ingredients
Ingredient NameStrength
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
POLYVINYL ALCOHOL (UNII: 532B59J990)  
POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
WATER (UNII: 059QF0KO0R)  
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
SORBITOL (UNII: 506T60A25R)  
TALC (UNII: 7SEV7J4R1U)  
TARTARIC ACID (UNII: W4888I119H)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10742-8117-15 in 1 POUCH; Type 0: Not a Combination Product04/10/200812/31/2015
2NDC:10742-8117-25 in 1 POUCH; Type 0: Not a Combination Product04/10/200812/31/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34804/10/200812/31/2015
Labeler - The Mentholatum Company (002105757)

Revised: 11/2016
Document Id: ed396d76-3551-4c04-8e93-cbd70e3c8346
Set id: 09c95d9b-aec9-47d2-93b4-1a33b44dd0ff
Version: 2
Effective Time: 20161104
 
The Mentholatum Company