Salonpas Patch
FDA Label NDC 46581-871

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Hisamitsu Pharmaceutical Co., Inc. for the product Salonpas (NDC 46581-871). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients, purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor if, if pregnant or breast-feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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

  • 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.

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

Other Information

  • Avoid storing product in direct sunlight
  • Protect product from excessive moisture

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 format
WORLD'S BRAND NO.1

IMPROVED ADHESION

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

    IMPROVED ADHESION

    Hisamitsu

    NDC#46581-871-99

    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

      Better adhesion
      Rounded corner

      Easy application
      Center-cut film

      All direction stretchable

      SAMPLE NOT FOR RE-SALE

      1 PATCH 3 15/16 X 5 1/2 (10cm X 14cm)

      MADE IN JAPAN

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