Your browser does not support JavaScript! MENTHOLATUM DEEP HEATING RUB EXTRA STRENGTH (MENTHOL, METHYL SALICYLATE) CREAM [THE MENTHOLATUM COMPANY]
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RxNorm Names

MENTHOLATUM DEEP HEATING RUB EXTRA STRENGTH (menthol, methyl salicylate) cream
[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 ingredients

Menthol 8%

Methyl salicylate 30%

Purpose

Menthol - External analgesic

Methyl salicylate - External analgesic

Uses

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

arthritis
strains
simple backache
sprains

Warnings

For external use only

When using this product

use only as directed
do not get into eyes or on mucous membranes
do not apply to wounds or damaged skin
do not bandage tightly
do not use with heating pad or apply external heat

Stop use and ask a doctor if

condition worsens
excessive irritation of the skin develops
pain persists 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 2 years and over: apply to affected area not more than 3 to 4 times daily
children under 2 years: ask a doctor

Inactive ingredients

glyceryl stearate, isoceteh-20, poloxamer 407, purified water, quaternium-15, sodium lauryl sulfate, sorbitan stearate

Questions or comments?

Toll free 1-877-636-2677 MON-FRI 9 AM to 5 PM (EST)

www.mentholatum.com

Package/Label Principal Display Panel

Deep Heating Extra Strength Pain Relieving Rub
MENTHOLATUM DEEP HEATING RUB  EXTRA STRENGTH
menthol, methyl salicylate cream
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:10742-2002
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL80 mg  in 1 g
METHYL SALICYLATE (SALICYLIC ACID) METHYL SALICYLATE300 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
GLYCERYL MONOSTEARATE 
POLOXAMER 407 
WATER 
QUATERNIUM-15 
SODIUM LAURYL SULFATE 
SORBITAN MONOSTEARATE 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10742-2002-42 in 1 CARTON
157 g in 1 TUBE
2NDC:10742-2002-557 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34812/15/1992
Labeler - The Mentholatum Company (002105757)

Revised: 12/2013
 
The Mentholatum Company

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