SPL v12
SPL
SPL Set ID ef5373aa-9857-4d01-95af-2d7716e54ae4
Route
TOPICAL
Published
Effective Date 2025-12-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Inactive Ingredients
Butylated Hydroxytoluene Natural Latex Rubber Silicon Dioxide Titanium Dioxide Zinc Oxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 1998-11-26 Until 2022-11-30

Description

Capsicum extract  0.025% as Capsaicin

Purpose

Topical analgesic


Medication Information

Purpose

Topical analgesic

Description

Capsicum extract  0.025% as Capsaicin

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 patch from film
  • 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

Do Not Use
  • on wounds or damaged skin 
  • with a heating pad
  • if you are allergic to any ingredients of this product
Active Ingredient

Capsicum extract  0.025% as Capsaicin

Other Information
  • Avoid storing product in direct sunlight
  • Protect product from excessive moisture
Inactive Ingredients

butylated hydroxytoluene, hydrogenated rosin glycerol ester, maleated rosin glycerin ester, natural rubber latex, polybutene, polyisobutylene, silicon dioxide, titanium dioxide, zinc oxide

Questions Or Comments?

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

Principal Display Panel

3 LARGE FOLDED PATCHES

5.12" X 7.09"(13 cm X 18 cm)

OTC topical analgesics in patch category*

WORLD'S BRAND NO.1

Hisamitsu

NDC#46581-700-03

for temporary relief of minor aches and pains of muscles and joints associated with

Simple backache

Arthritis

Strains

Bruises

Sprains

Salonpas-HOT

CAPSICUM Patch

Topical Analgesic

3 FOLDED PATCHES

5.12" X 7.09" (13cm X 18cm)

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
  • 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.


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 patch from film
  • 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

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
Active Ingredient (Active ingredient)

Capsicum extract  0.025% as Capsaicin

Other Information (Other information)
  • Avoid storing product in direct sunlight
  • Protect product from excessive moisture
Inactive Ingredients (Inactive ingredients)

butylated hydroxytoluene, hydrogenated rosin glycerol ester, maleated rosin glycerin ester, natural rubber latex, polybutene, polyisobutylene, silicon dioxide, titanium dioxide, zinc oxide

Questions Or Comments? (Questions or comments?)

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

Principal Display Panel

3 LARGE FOLDED PATCHES

5.12" X 7.09"(13 cm X 18 cm)

OTC topical analgesics in patch category*

WORLD'S BRAND NO.1

Hisamitsu

NDC#46581-700-03

for temporary relief of minor aches and pains of muscles and joints associated with

Simple backache

Arthritis

Strains

Bruises

Sprains

Salonpas-HOT

CAPSICUM Patch

Topical Analgesic

3 FOLDED PATCHES

5.12" X 7.09" (13cm X 18cm)

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)
  • 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, (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

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