Salonpas pain relieving MASSAGE

Dosage form: aerosol, foam
Ingredients: Menthol 3.0g in 100g, Methyl salicylate 10.0g in 100g
Labeler: Hisamitsu Pharmaceutical Co., Inc.
NDC Code: 46581-480

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.

Drug Facts

Active ingredients

Menthol 3%

Methyl salicylate 10%

Purpose

Topical analgesic

Uses

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

  • strains
  • sprains
  • bruises
  • simple backache
  • arthritis

Warnings

For external use only

Allergy alert:

If prone to allergic reaction from aspirin or salicylates, consult a doctor before use.

Flammable:
  • keep away from the fire or flame.
  • do not use where sparks come out.
  • do not use in a confined space.
  • do not puncture or incinerate container. Contents under pressure.
  • do not expose to temperature exceeding 120 degrees F (48 degrees C).

Do not use
  • on wounds or damaged skin.
  • with a heating pad.
  • 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.
  • avoid inhalation.

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.

If pregnant or breast-feeding,

ask a health 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 of age and over:

  • shake the can very well before use.
  • spray and dispense foam onto fingertips or palm no longer than 3 seconds, and massage well on the affected area until the crackling sound stops.
  • do not use upside down.
  • apply to affected area not more than 3 to 4 times daily.

Children under 12 years of age: consult a doctor.

Other information
  • avoid storing product in direct sunlight and heat.

Inactive ingredients

alcohol, ceteth-20, hydroxyethylcellulose, laureth-2, PEG-40 hydrogenated castor oil, polysorbate 20, talc, water

Questions or comments?

Toll free 1-800-826-8861, Weekdays, 9AM to 5PM (PST) www.salonpas.us

Principal Display PanelSalonpas pain relieving MASSAGE FOAM
NDC#46581-480-04
4FL OZ (118mL)
Hisamitsu
SALONPAS PAIN RELIEVING MASSAGE 
menthol, methyl salicylate aerosol, foam
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:46581-480
Route of AdministrationTOPICAL, PERCUTANEOUS, TRANSDERMALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Menthol (Menthol) Menthol3.0 g  in 100 g
Methyl salicylate (Salicylic acid) Methyl salicylate10.0 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
Alcohol 
Polysorbate 20 
Polyoxyl 40 hydrogenated castor oil 
Laureth-2 
Ceteth-20 
Water 
Hydroxyethyl cellulose (3000 CPS AT 1%) 
Talc 
Packaging
#Item CodePackage Description
1NDC:46581-480-0432.8 g in 1 CAN
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34805/01/2011
Labeler - Hisamitsu Pharmaceutical Co., Inc. (690539713)
Registrant - Hisamitsu Pharmaceutical Co., Inc. (690539713)

Revised: 04/2011
 
Hisamitsu Pharmaceutical Co., Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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