MENTHOLATUM DEEP HEATING RUB EXTRA STRENGTH- menthol, methyl salicylate cream 
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 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, sodium lauryl sulfate, sorbitan stearate

Questions?

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

www.mentholatum.com

Package/Label Principal Display Panel

Mentholatum Deep Heating Pain Relieving Rub
MENTHOLATUM DEEP HEATING RUB  EXTRA STRENGTH
menthol, methyl salicylate cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:10742-2002
Route of Administration TOPICAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM 80 mg  in 1 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE 300 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
POLOXAMER 407 (UNII: TUF2IVW3M2)  
WATER (UNII: 059QF0KO0R)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:10742-2002-4 2 in 1 CARTON 12/15/1992
1 57 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 12/15/1992
Labeler - The Mentholatum Company (002105757)

Revised: 11/2017
Document Id: d2fcc150-e64a-4598-8c34-cb34c1c641d4
Set id: f5684158-0d83-4031-b493-5422ddc73e78
Version: 4
Effective Time: 20171108
 
The Mentholatum Company