SPL v10
SPL
SPL Set ID d2aa8820-a947-404b-b617-e692fbd16502
Route
TOPICAL
Published
Effective Date 2025-12-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (0.025 g)
Inactive Ingredients
Edetate Disodium Gelatin, Unspecified Glycerin Silodrate Oleyl Alcohol Polyvinyl Alcohol, Unspecified Propylene Glycol Sorbitan Monooleate Tartaric Acid Titanium Dioxide Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-01-01 Until 2022-11-30

Description

Capsicum extract 0.025% as Capsaicin Menthol 1.25%

Purpose

Topical analgesic


Medication Information

Purpose

Topical analgesic

Description

Capsicum extract 0.025% as Capsaicin Menthol 1.25%

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

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 hour-application

Children under 12 years of age: consult a doctor

Do Not Use
  • on wounds or damaged skin
  • with a heating pad
  • if you are allergic to any ingredients of this product
Other Information
  • Avoid storing product in direct sunlight
  • Protect product from excessive moisture
Active Ingredients

Capsicum extract 0.025% as Capsaicin

Menthol 1.25%

Inactive Ingredients

edetate disodium, gelatin, glycerin, magnesium aluminometasilicate, methylacrylate/2-ethylhexyl acrylate copolymer, nonoxynol, oleyl alcohol, polyacrylic acid, polyvinyl alcohol, propylene glycol, sodium polyacrylate, sorbitan monooleate, tartaric acid, titanium dioxide, water

Questions Or Comments?

Toll free 1-800-826-8861 www.salonpas.us

Principal Display Panel

OTC topical analgesics in patch category*

WORLD'S BRAND NO.1

Hisamitsu

NDC#46581-871-06

for minor aches and pain relief

Back

Neck

Shoulders

Knees and Elbows

Salonpas Pain Relieving Gel-Patch HOT

Capsaicin 0.025%

Menthol 1.25%

APPLY FOR 8 HOURS

STRETCHABLE

6 PATCHES 3 15/16" X 5 1/2" (10cm X 14cm)

MADE IN JAPAN

When Using This Product
  • use only 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
  • skin reactions such as redness, itching, rash, excessive irritation, buring sensation, swelling or blistering occur
  • 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.


Structured Label Content

Uses

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

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains
Purpose

Topical analgesic

Warnings

For external use only

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 hour-application

Children under 12 years of age: consult a doctor

Do Not Use (Do not use)
  • on wounds or damaged skin
  • with a heating pad
  • if you are allergic to any ingredients of this product
Other Information (Other information)
  • Avoid storing product in direct sunlight
  • Protect product from excessive moisture
Active Ingredients (Active ingredients)

Capsicum extract 0.025% as Capsaicin

Menthol 1.25%

Inactive Ingredients (Inactive ingredients)

edetate disodium, gelatin, glycerin, magnesium aluminometasilicate, methylacrylate/2-ethylhexyl acrylate copolymer, nonoxynol, oleyl alcohol, polyacrylic acid, polyvinyl alcohol, propylene glycol, sodium polyacrylate, sorbitan monooleate, tartaric acid, titanium dioxide, water

Questions Or Comments? (Questions or comments?)

Toll free 1-800-826-8861 www.salonpas.us

Principal Display Panel

OTC topical analgesics in patch category*

WORLD'S BRAND NO.1

Hisamitsu

NDC#46581-871-06

for minor aches and pain relief

Back

Neck

Shoulders

Knees and Elbows

Salonpas Pain Relieving Gel-Patch HOT

Capsaicin 0.025%

Menthol 1.25%

APPLY FOR 8 HOURS

STRETCHABLE

6 PATCHES 3 15/16" X 5 1/2" (10cm X 14cm)

MADE IN JAPAN

When Using This Product (When using this product)
  • use only 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 (Stop use and ask a doctor if)
  • skin reactions such as redness, itching, rash, excessive irritation, buring sensation, swelling or blistering occur
  • conditions worsen
  • symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days
If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)