FDA.reportPublic FDA data

® Tablets

Manufacturer
Bryant Ranch Prepack
Effective date
2022-02-22
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 22:06:50

Label at a glance#

ProductSalonpas
Active ingredientCAMPHOR (SYNTHETIC), MENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE
Label structure10 sections

Indications and uses

For temporary relief of minor aches and pains of muscles and joints associated with: arthritis simple backache strains bruises sprains

Dosage and administration

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

Storage and handling

avoid storing product in direct sunlight protect product from excessive moisture

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Camphor 3.1%

Menthol 6.0%

Methyl salicylate 10.0%

Purpose

OTC - PURPOSE SECTION

Topical analgesic

Uses

INDICATIONS & USAGE SECTION

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

  • arthritis
  • simple backache
  • strains
  • bruises
  • sprains

Warnings

WARNINGS SECTION

For external use only

Allergy alert:

OTC - ASK DOCTOR SECTION

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

Do not use

OTC - DO NOT USE SECTION

  • on wounds or damaged skin
  • with a heating pad
  • if you are allergic to any ingredients of this product

When using this product

OTC - WHEN USING SECTION

  • use only as directed
  • avoid contact with the eyes, mucous membranes or rashes
  • do not bandage tightly

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • 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,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

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

Other information

STORAGE AND HANDLING SECTION

  • avoid storing product in direct sunlight
  • protect product from excessive moisture

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

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

HOW SUPPLIED

How Supplied Section

NDC: 63629-8310-1: 20 Patchs in a POUCH

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Salonpas Pain Relief Blister patch

Label
Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63629-8310-12025-01-28C16284748780-11030e365-4f7c-111a-e063-dadaa90a10e2® Tablets
63629-8310-12024-01-30C16284748780-11030e365-4f7c-111a-e063-dadaa90a10e2® Tablets

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
46581-110-20EA - Each46581-110e01f4fa0-af82-4a78-880d-d1a731e1360a12020-07-13
46581-110-60EA - Each46581-110324efea9-ebf1-4441-8cdc-97ae0a684d9a12020-07-13

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63629-831063629-8310-1
46581-110

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
CAMPHOR (SYNTHETIC)5TJD82A1ETACTIB
MENTHOL, UNSPECIFIED FORML7T10EIP3AACTIB
METHYL SALICYLATELAV5U5022YACTIB
MINERAL OILT5L8T28FGPIACT
ALUMINUM SILICATET1FAD4SS2MIACT
TITANIUM DIOXIDE15FIX9V2JPIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
a3d9f956-2c34-40b3-9317-cf5e23f853b0e5a244fc-8c20-455e-a7cd-d1bc0c6e50c72025-01-28WarningsExact identifier
spl set id: e5a244fc-8c20-455e-a7cd-d1bc0c6e50c7
SalonpasCAMPHOR, MENTHOL, METHYL SALICYLATEHisamitsu Pharmaceutical Co., Inc.acdd5622-a9a7-4cc3-877e-57efea23303f2024-12-03WarningsExact identifier
ndc (product): 46581-110

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.