Salonpas pain relieving GEL-PATCH HOT

Dosage form: ointment
Ingredients: Capsicum oleoresin 17.5mg, Menthol 175mg
Labeler: Hisamitsu Pharmaceutical Co., Inc.
NDC Code: 46581-870

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

Capsicum extract  0.025% as Capsaicin

Menthol 1.25%

Purpose

Topical analgesic

Uses

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

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains

Warnings

For external use only

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.
  • discontinue use at least 1 hour before a bath or shower.
  • do not use immediately after a bath or shower.

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.
  • remove 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

aluminum silicate, edetate disodium, gelatin, glycerin, magnesium aluminometasilicate, oleyl alcohol, polyacrylic acid, polyethylene glycol, polyvinyl alcohol, sodium polyacrylate, sorbitan monooleate, tartaric acid, titanium dioxide, water

Questions or comments?

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

Principal Display Panel

NDC#46581-870-06

for minor aches and pain relief

  • Shoulder
  • Upper Back
  • Lower Back
Salonpas pain relieving GEL-PATCH HOT
Capsaicin 0.025%
Menthol 1.25%
LASTS UP TO 8 HOURS
Pain Relieving Ointment on a Breathable Cloth
STRETCHABLE
6 patches 3 15/16 X 5 1/2 inch (10cm X 14cm)
Hisamitsu

Principal Display Panel

NDC#46581-870-01

for minor aches and pain relief

  • Shoulder
  • Upper Back
  • Lower Back
1. Pull apart.
2. Place on affected area.
3. Slide the both films.
4. Gently apply the patch.

Salonpas pain relieving GEL-PATCH HOT
Capsaicin 0.025%
Menthol 1.25%

LASTS UP TO 8 HOURS
Pain Relieving Ointment on a Breathable Cloth
STRETCHABLE
1 patch 3 15/16" X 5 1/2" (10cm X 14cm)
Hisamitsu

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

Distributed by
Hisamitsu America, Inc.
Torrance, CA 90503

Principal Display Panel

NDC#46581-870-99

for minor aches and pain relief

  • Shoulder
  • Upper Back
  • Lower Back
1. Pull apart.
2. Place on affected area.
3. Slide the both films.
4. Gently apply the patch.

Salonpas pain relieving GEL-PATCH HOT
Capsaicin 0.025%
Menthol 1.25%

LASTS UP TO 8 HOURS
Pain Relieving Ointment on a Breathable Cloth
STRETCHABLE
1 patch 3 15/16" X 5 1/2" (10cm X 14cm)
Hisamitsu

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

Destributed by
Hisamitsu America, Inc.
Torrance, CA 90503

FREE SAMPLE
NOT FOR RE-SALE



SALONPAS PAIN RELIEVING GEL-PATCH HOT 
capsaicin, menthol ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:46581-870
Route of AdministrationTOPICAL, PERCUTANEOUS, TRANSDERMALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Capsicum oleoresin (Capsicum oleoresin) Capsicum oleoresin17.5 mg
Menthol (Menthol) Menthol175 mg
Inactive Ingredients
Ingredient NameStrength
Gelatin 
Polyvinyl alcohol 
Titanium dioxide 
Aluminum silicate 
Edetate disodium 
Polyethylene glycol 400 
Glycerin 
Sorbitan monooleate 
Oleyl alcohol 
Tartaric acid 
Water 
Packaging
#Item CodePackage Description
1NDC:46581-870-062 POUCH (POUCH) in 1 BOX
13 OINTMENT (PATCH) in 1 POUCH
2NDC:46581-870-011 OINTMENT (PATCH) in 1 POUCH
3NDC:46581-870-991 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 drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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