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Salonpas® Pain Relief Patch Large

The first and only FDA-Approved OTC topical pain relief patch. Provides temporary relief of mild to MODERATE aches & pains of muscles & joints associated with: strains, sprains, simple backache, arthritis and bruises.

  • Up to 12 Hours of Powerful Relief
  • Proven Efficacy for Mild to Moderate Pain
  • Safe Alternative to Opioids & Oral NSAIDs
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Salonpas® Product Information

Product Highlights
  • Clinically proven for mild to moderate pain
  • Powerful Relief that lasts up to 12 hours
  • Number of Patches: 9 Count
  • Patch Size: 3 15/16" × 5 1/2" (10cm x 14cm)
  • A smaller patch (2 3/4" x 3 15/16" or 7cm x 10cm) is available in a 20 count
Product Description

Salonpas Pain Relief Patch contains two powerful pain fighting ingredients, menthol and methyl salicylate (an NSAID – a nonsteroidal anti-inflammatory drug). It is the first and only FDA-approved OTC topical pain relief patch clinically proven for mild to moderate pain. And, it lasts for up to 12 hours.

Ingredients

Ingredients

Active Ingredients:

  • Menthol 3% (Topical analgesic)
  • Methyl salicylate 10% (NSAID) (Topical analgesic)

Inactive Ingredients:

alicyclic saturated hydrocarbon resin, backing cloth, film, mineral oil, polyisobutylene, polyisobutylene 1,200,000, styrene-isoprene-styrene block copolymer, synthetic aluminum silicate

Application Instructions

Adults 18 years and older:

  1. Only use one patch at a time
  2. Clean and dry affected area
  3. Remove patch from backing film and apply to skin (see illustration)
  4. Apply one patch to the affected area and leave in place for up to 8 to 12 hours
  5. If pain lasts after using the first patch, a second patch may be applied for up to another 8 to 12 hours
  6. Do not use more than 2 patches per day
  7. Do not use for more than 3 days in a row
  8. The used patch should be removed from the skin when a new one is applied

Children under 18 years of age: do not use; this product has not been shown to work in children

Product Warnings
Warnings:
For external use only
Stomach bleeding warning:
This product contains an NSAID, which may cause stomach bleeding. The chance is small but higher if you:

Are age 60 or older
Have had stomach ulcers or bleeding problems
Take a blood thinning (anticoagulant) or steroid drug
Take other drugs containing an NSAID (aspirin, ibuprofen, naproxen, or others)
Have 3 or more alcoholic drinks every day while using this product
Take more or for a longer time than directed
Do not use:
On the face or rashes
On wounds or damaged skin
If allergic to aspirin or other NSAIDs
With a heating pad
When sweating (such as from exercise or heat)
Any patch from a pouch that has been open for 14 or more days
Right before or after heart surgery
Ask a doctor before use if:
You are allergic to topical products
The stomach bleeding warning applies to you
You have high blood pressure, heart disease, or kidney disease
You are taking a diuretic
When using this product:
Wash hands after applying or removing patch. Avoid contact with eyes. If eye contact occurs, rinse thoroughly with water.
The risk of heart attack or stroke may increase if you use more than directed or for longer than directed
Stop use and ask a doctor if:
Stomach pain or upset gets worse or lasts
You feel faint, vomit blood, or have bloody or black stools. These are signs of stomach bleeding.
Rash, itching or skin irritation develops
Condition worsens
Symptoms last for more than 3 days
Symptoms clear up and occur again within a few days

If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use methyl salicylate at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Keep out of reach of children: If put in mouth, get medical help or contact a Poison Control Center right away. Package not child resistant. Dispose of the used patches after folding sticky ends together.

Other Information
  • Store at 20-25°C (68-77°F)
  • Avoid storing product in direct sunlight
  • Protect product from excessive moisture
  • Some individuals may not experience pain relief until several hours after applying the patch
Mechanism of Action

Salonpas® Pain Relief Patch Large interrupts key pathways

Salonpas® Pain Relief Patch Large is believed to have multiple mechanisms of action with counterirritant effects contributed by both methyl salicylate and menthol.

Mechanism of Action diagram for Salonpas® Pain Relief Patch Large
Clinical Research

Higashi Study Highlights & Related Information

A randomized, double-blind, parallel-group, placebo-controlled, multicenter study, reviewed and confirmed by the FDA’s New Drug Application process, means this is an OTC topical analgesic that has clinical proof and approval few have.

Strong Clinical Trial Results

  • 40% additional relief experienced with Salonpas® vs placebo
  • 58% study patients rating satisfaction from Salonpas® as good/very good/excellent
  • From a randomized, double-blind, parallel-group, placebo-controlled, multicenter study1

Passed Rigorous FDA Review

  • <10% of OTC drug products have an NDA or have even been reviewed by the FDA
  • Salonpas® is the first and only OTC topical pain relief patch to earn an NDA
  • The FDA’s New Drug Application (NDA) process is a rigorous process that every prescription medicine has passed through since 1938.

Long-Lasting, Controlled Dose

Treatment works locally, significant pain relief can start within 1 hour and lasts for up to 12 hours, with very little medicine traveling throughout the bloodstream. Some individuals may not experience pain relief until several hours after applying the patch.

Footnotes

  1. Higashi, et al Clinical Therapeutics/Volume 32, Number 1 ↩
  • Salonpas® Pain Relief Patch Large box
  • Salonpas® Pain Relief Patch Large Drug Facts Label