SALONPAS- menthol and methyl salicylate gel 
Hisamitsu Pharmaceutical Co., Inc.

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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Active Ingredients

Menthol 7%

Methyl Salicylate 15%

Purpose

Topical Analgesic

Uses

For temporary relief of minor aches and pains of muscles and joints associated with:

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains

Warnings

For external use only

Do not use

  • on wounds or damaged skin.
  • if you are allergic to aspirin or salicylates.
  • with a heating pad.
  • with, or at the same times as, other external analgesic products.

Ask a doctor before use,

if you are allergic to any ingredients of this product.

When using this product

  • do not use otherwise than as directed.
  • avoid contact with the eyes, mucous membranes or rashes.
  • do not bandage tightly.

Stop use and ask a doctor if

  • rash, itching or excessive skin irritation develops.
  • conditions worsen.
  • symptoms persist 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 of age and over:

  • Clean and dry affected area.
  • Apply to affected area not more than 3 to 4 times daily for 7 days.

Children under 2 years of age:

  • Consult a doctor.

Other Information

  • Avoid storing product in direct sunlight.
  • Protect product from excessive moisture.

Inactive ingredients

Carbomer, Denatured Alcohol, Hydroxypropyl Cellulose, Perfume, Polyoxyethylene Oleylamine, Propylene Glycol, Water

Principal Display Panel

FOR TEMPORARY RELIEF OF MINOR ACHES AND PAINS OF MUSCLES AND JOINTS

Hisamitsu

TOPICAL ANALGESIC

For External Use Only

SALONPAS GEL

Stainless Greaseless Fast Absorbing NET WT. 1.41 oz. (40g)

image of 40g box label

SALONPAS 
menthol, methyl salicylate gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:46581-600
Route of AdministrationTOPICAL, PERCUTANEOUS, TRANSDERMALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL7.0 g  in 100 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE15.0 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:46581-600-401 in 1 BOX
140 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:46581-600-252.5 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 finalpart34802/25/198906/30/2015
Labeler - Hisamitsu Pharmaceutical Co., Inc. (690539713)

Revised: 5/2015
Document Id: 710fa724-ab4e-4f39-b827-a533213c1773
Set id: 0f9d82be-de77-42a9-a6ee-1778846bdf81
Version: 2
Effective Time: 20150508
 
Hisamitsu Pharmaceutical Co., Inc.