MENTHOLATUM PAIN RELIEF EXTRA STRENGTH- menthol gel 
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 3%

Purpose

Topical analgesic

Uses

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

•
simple backache
•
arthritis
•
strains
•
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 to damaged or very sensitive skin
•
do not bandage tightly or cover with any type of wrap except clothing
•
do not bandage tightly

Stop use and ask a doctor if

•
condition worsens
•
excessive irritation, burning or discomfort of the skin develops
•
symptoms persist for more than 7 days or clear up and occur again within a few days

If pregnant or breast-feeding,

ask a healthcare 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 to affected area not more than 3 to 4 times daily
•
children under 12 years: ask a doctor

Inactive ingredients

carbomer, iron oxides, isopropyl alcohol, methylparaben, mica, propylparaben, purified water, titanium dioxide, trolamine

Questions?

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

Distributed by:

The Mentholatum Company

Orchard Park, NY 14127

Made in Canada

Package/Label Principal Display Panel

Mentholatum Pain Relief Extra Strength Gel Menthol 3%

Mentholatum Pain Relief Extra Strength Gel

Package/Label Principal Display Panel

Active ingredient Menthol 3% Topical analgesic

Distributed by:

The Mentholatum Company

Orchard Park, NY 14127

Made in Canada

MENTHOLATUM PAIN RELIEF EXTRA STRENGTH 
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10742-8134
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM30 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
MICA (UNII: V8A1AW0880)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TROLAMINE (UNII: 9O3K93S3TK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10742-8134-1236 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/08/201112/31/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34808/08/201112/31/2015
Labeler - The Mentholatum Company (002105757)

Revised: 11/2016
Document Id: 937d0439-12a8-4f57-943e-3f5f9926463e
Set id: d7ea3cfc-dc14-4039-ac6b-7176dbe70cf5
Version: 2
Effective Time: 20161104
 
The Mentholatum Company