Your browser does not support JavaScript! COLD AND HOT MEDICATED (MENTHOL) PATCH [THE MENTHOLATUM COMPANY]
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RxNorm Names

COLD AND HOT MEDICATED (menthol) patch
[The Mentholatum Company]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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 Label Sections

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 DRUG LABELItem Code (Source)NDC:10742-8117
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL50 mg
Inactive Ingredients
Ingredient NameStrength
CARBOXYMETHYLCELLULOSE SODIUM 
DIHYDROXYALUMINUM AMINOACETATE 
EDETATE DISODIUM 
GLYCERIN 
ISOPROPYL MYRISTATE 
POLYVINYL ALCOHOL 
POLYACRYLIC ACID (250000 MW) 
POLYSORBATE 80 
WATER 
SORBITAN SESQUIOLEATE 
SORBITOL 
TALC 
TARTARIC ACID 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10742-8117-15 in 1 POUCH
2NDC:10742-8117-25 in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34804/10/2008
Labeler - The Mentholatum Company (002105757)

Revised: 4/2013
 
The Mentholatum Company

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