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

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, other heat sources, or right after a shower/bath
  • do not use in combination with other external analgesic products

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

Inactive ingredients

glyceryl stearate, isoceteh-20, poloxamer, purified water, sodium lauryl sulfate, sorbitan monostearate, trolamine

Questions?

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

www.mentholatum.com

Package/Label Principal Display Panel

Deep Heating PDP

Principal Display Panel

Drug Facts
MENTHOLATUM DEEP HEATING RUB   EXTRA STRENGTH
menthol, methyl salicylate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10742-2002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM80 mg  in 1 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE300 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
ISOCETETH-20 (UNII: O020065R7Z)  
POLOXAMER 407 (UNII: TUF2IVW3M2)  
WATER (UNII: 059QF0KO0R)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
TROLAMINE (UNII: 9O3K93S3TK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10742-2002-42 in 1 CARTON12/15/1992
157 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34812/15/1992
Labeler - The Mentholatum Company (002105757)
Registrant - The Mentholatum Company (002105757)
Establishment
NameAddressID/FEIBusiness Operations
The Mentholatum Company002105757manufacture(10742-2002)

Revised: 2/2023
Document Id: f41f0e08-995d-0f1b-e053-2995a90a6639
Set id: f5684158-0d83-4031-b493-5422ddc73e78
Version: 8
Effective Time: 20230207
 
The Mentholatum Company