SPL v9
SPL
SPL Set ID acdd5622-a9a7-4cc3-877e-57efea23303f
Routes
TOPICAL PERCUTANEOUS TRANSDERMAL
Published
Effective Date 2024-12-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Camphor (synthetic) (21.56 mg) Menthol (41.73 mg) Salicylic Acid (69.55 mg)
Inactive Ingredients
Mineral Oil Aluminum Silicate Titanium Dioxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2015-06-01

Description

Camphor 3.1% Menthol 6.0% Methyl salicylate 10.0%

Purpose

Topical analgesic


Medication Information

Purpose

Topical analgesic

Description

Camphor 3.1% Menthol 6.0% Methyl salicylate 10.0%

Uses

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

  • arthritis
  • simple backache
  • 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-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
Allergy Alert:

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

Other Information
  • avoid storing product in direct sunlight
  • protect product from excessive moisture
Active Ingredients

Camphor 3.1%

Menthol 6.0%

Methyl salicylate 10.0%

Inactive Ingredients

mineral oil, perfume, polyisobutylene, styrene-isoprene-styrene block copolymer, synthetic aluminum silicate, terpene resin, titanium dioxide

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#46581-110-60

for temporary relief of minor aches and pains

STIFF NECK

SORE SHOULDER

BACKACHE

JOINT PAIN

Salonpas

Pain Relieving Patch

APPLY FOR 8 HOURS

60 PATCHES

2.83" X 1.81" (7.2cm X 4.6cm)

MADE IN JAPAN

When Using This Product
  • use only 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.


Structured Label Content

Uses

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

  • arthritis
  • simple backache
  • 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-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
Allergy Alert: (Allergy alert:)

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

Other Information (Other information)
  • avoid storing product in direct sunlight
  • protect product from excessive moisture
Active Ingredients (Active ingredients)

Camphor 3.1%

Menthol 6.0%

Methyl salicylate 10.0%

Inactive Ingredients (Inactive ingredients)

mineral oil, perfume, polyisobutylene, styrene-isoprene-styrene block copolymer, synthetic aluminum silicate, terpene resin, titanium dioxide

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#46581-110-60

for temporary relief of minor aches and pains

STIFF NECK

SORE SHOULDER

BACKACHE

JOINT PAIN

Salonpas

Pain Relieving Patch

APPLY FOR 8 HOURS

60 PATCHES

2.83" X 1.81" (7.2cm X 4.6cm)

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
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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