Salonpas pain relieving GEL-PATCH HOT -L

Dosage form: ointment
Ingredients: CAPSICUM 1250mg, MENTHOL 250mg
Labeler: Hisamitsu Pharmaceutical Co., Inc.
NDC Code: 46581-890

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.

Active ingredients

Capsicum extract   0.025% as Capsaicin

Menthol 1.25%

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
  • 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
  • protect product from excessive moisture

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  www.salonpas.us

Principal Display Panel

LARGE

NDC#46581-890-03

for minor aches and pain relief

  • Shoulder
  • Upper Back
  • Lower Back

Salonpas pain relieving GEL-PATCH HOT-L

Capsaicin 0.025%

Menthol 1.25%

LASTS UP TO 8 HOURS

Pain Relieving Ointment on a Breathable Cloth

STRETCHABLE

3 patches 3 15/16 X 7 7/8 (10cm X 20cm)

Hisamitsu

SALONPAS PAIN RELIEVING GEL-PATCH HOT  -L
capsaicin, menthol ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:46581-890
Route of AdministrationTOPICAL, PERCUTANEOUS, TRANSDERMALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAPSICUM (CAPSICUM) CAPSICUM1250 mg
MENTHOL (MENTHOL) MENTHOL250 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:46581-890-031 POUCH in 1 BOX
13 OINTMENT in 1 POUCH
2NDC:46581-890-011 OINTMENT in 1 POUCH
3NDC:46581-890-991 OINTMENT 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)

Revised: 12/2013
 
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.

Hide
(web4)