Salonpas pain relieving PATCH -L

Dosage form: ointment
Ingredients: Menthol 31.5mg, Methyl salicylate 210mg
Labeler: Hisamitsu Pharmaceutical Co., Inc.
NDC Code: 46581-630

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 1.5%

Methyl salicylate 10%

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

Allergy alert:

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

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.

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:

  • clean and dry affected area.
  • peel film from patch and apply to the skin. (see illustration.)
  • apply to affected area not more than 3 to 4 times daily.
  • remove patch from the skin after at most 8 hours' application.
Children under 12 years of age: consult a doctor.

Other information
  • avoid storing product in direct sunlight and heat.
  • store at cool and dry place.

Inactive ingredients

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

Questions or comments?

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

Principal Display Panel

LARGE

NDC#46581-630-03

for minor aches and pain relief

  • Shoulder
  • Upper Back
  • Lower Back
Salonpas pain relieving PATCH-L
Menthol 1.5%
Methyl Salicylate 10%
LASTS UP TO 8 HOURS
Pain Relieving Ointment on a Breathable Cloth
Beige Color
Ultra Thin COMFORT STRETCH
3 patches 3 15/16 X 5 1/2 inch (10cm X 14cm)
Hisamitsu

Principal Display Panel

Cut open easily by hand

LARGE

NDC#46581-630-01

for minor aches and pain relief

  • Shoulder
  • Upper Back
  • Lower Back
1. Peel the center film.
2. Place on affected area.
3. Slide a film.
4. Slide the other film.

Salonpas pain relieving PATCH-L
Menthol 1.5%
Methyl salicylate 10%

LASTS UP TO 8 HOURS
Pain Relieving Ointment on a Breathable Cloth
Beige Color
Ultra Thin COMFORT STRETCH
1 patch 3 15/16 X 5 1/2 inch (10cm X 14cm)
Hisamitsu

Manufactured by
Hisamitsu Pharmaceutical Co., Inc.
JAPAN SAGA TOSU
MADE IN JAPAN

Distributed by
Hisamistu America, Inc.
Torrance, CA 90503

Principal Display Panel

Cut open easily by hand

LARGE

FREE SAMPLE NOT FOR RE-SALE

NDC#46581-630-99

for minor aches and pain relief

  • Shoulder
  • Upper Back
  • Lower Back
1. Peel the center film.
2. Place on affected area.
3. Slide a film.
4. Slide the other film.

Salonpas pain relieving PATCH-L
Menthol 1.5%
Methyl Salicylate 10%
LASTS UP TO 8 HOURS
Pain Relieving Ointment on a Breathable Cloth
Beige Color
Ultra Thin COMFORT STRETCH
1 patch 3 15/16 X 5 1/2 inch (10cm X 14cm)
Hisamitsu

Manufactured by
Hisamitsu Pharmaceutical Co., Inc.
JAPAN SAGA TOSU
MADE IN JAPAN

Distributed by
Hisamitsu America, Inc.
Torrance, CA 90503
SALONPAS PAIN RELIEVING PATCH  -L
menthol, methyl salicylate ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:46581-630
Route of AdministrationTOPICAL, PERCUTANEOUS, TRANSDERMALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Menthol (Menthol) Menthol31.5 mg
Methyl salicylate (Salicylic acid) Methyl salicylate210 mg
Inactive Ingredients
Ingredient NameStrength
Aluminum silicate 
Mineral oil 
Packaging
#Item CodePackage Description
1NDC:46581-630-031 POUCH (POUCH) in 1 BOX
13 OINTMENT (PATCH) in 1 POUCH
2NDC:46581-630-011 OINTMENT (PATCH) in 1 POUCH
3NDC:46581-630-991 OINTMENT (PATCH) in 1 POUCH
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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