Soundbody medicated patch

Manufacturer
Kareway Product, Inc.
Effective date
2023-02-17
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:54:09

Label at a glance#

ProductSoundbody medicated patch
Active ingredientCAMPHOR (SYNTHETIC), MENTHOL, METHYL SALICYLATE
Label structure8 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
  • contisions 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

hydrogenated poly, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, petroleum, styrene/isoprene copolymer

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

cartoncarton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1793147camphor 3.1 % / menthol 6 % / methyl salicylate 10 % Medicated PatchPSN2
1793147camphor 0.031 MG/MG / menthol 0.06 MG/MG / methyl salicylate 0.1 MG/MG Medicated PatchSCD2
1793147camphor 3.1 % / menthol 6 % / methyl salicylate 10 % Medicated PatchSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67510-0547-62025-01-30C16284748780-12cef2736-780c-d83d-e063-dadaa90ab31fSoundbody Medicated Pain Relief Patch

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67510-0547-6Soundbody medicated patch1 in 1 BOXPATCH12
67510-0547-6Soundbody medicated patch6 in 1 POUCHPATCH62

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67510-0547SOUNDBODY MEDICATED PATCH (CAMPHOR, MENTHOL, METHYL SALICYLATE) PATCH [KAREWAY PRODUCT, INC.]2Legacy NDC, 2 package rows20230219_9f07da88-b008-5b3f-e053-2995a90ac7d4.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
67510-054767510-0547-6

Ingredients#

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

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

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
f4ee6f6e-ffc8-4583-e053-2a95a90aa9609f07da88-b008-5b3f-e053-2995a90ac7d42023-02-17WarningsExact identifier
spl id: f4ee6f6e-ffc8-4583-e053-2a95a90aa960
spl set id: 9f07da88-b008-5b3f-e053-2995a90ac7d4

Reported adverse events (FAERS/openFDA)#

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