MENTHOLATUM PAIN RELIEVING- menthol, methyl salicylate lotion 
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 6%

Methyl salicylate 20%

Purpose

Menthol - Topical analgesic

Methyl salicylate - Topical analgesic

Uses

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

  • arthritis
  • simple backache
  • 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 skin
  • do not bandage tightly
  • do not use with a 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

  • 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, lanolin oil, polysorbate 60, purified water, sorbitan monosterate, trolamine

Package/Label Principal Display Panel

Mentholatum Pain Relieving Lotion
MENTHOLATUM PAIN RELIEVING 
menthol, methyl salicylate lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10742-8169
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM60 mg  in 1 mL
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE200 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
LANOLIN OIL (UNII: OVV5IIJ58F)  
MINERAL OIL (UNII: T5L8T28FGP)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
WATER (UNII: 059QF0KO0R)  
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
TROLAMINE (UNII: 9O3K93S3TK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10742-8169-11 in 1 CARTON11/01/2018
1100 mL in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:10742-8169-21 in 1 CARTON11/01/2018
275 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34811/01/2018
Labeler - The Mentholatum Company (002105757)
Registrant - The Mentholatum Company (002105757)
Establishment
NameAddressID/FEIBusiness Operations
The Mentholatum Company002105757manufacture(10742-8169)

Revised: 2/2023
Document Id: f41f7f2f-5725-5c8b-e053-2a95a90a43db
Set id: 0056b952-9870-485a-9f35-f985472875a9
Version: 2
Effective Time: 20230207
 
The Mentholatum Company