FDA.reportPublic FDA data

Soothing patch

Manufacturer
Fuzhou Ayimong Trading Co., Ltd.
Effective date
2024-02-25
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:09:00

Label at a glance#

ProductSoothing patch
Active ingredientBORNEOL
Label structure12 sections

Dosage and administration

Before use, please clean the skin of the affectedarea, peel off the protective film, and apply thispatch directly to the affected area.

Storage and handling

This product may cause occasional skin allergies. Ifyou find erythema or edema caused by skin irritationduring use, you should stop using it imediately.The erythema and edema will generally disappear ontheir own. If necessary, you can apply hormone drugsto the skin allergy area for treatment.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Borneol 5%

Purpose

OTC - PURPOSE SECTION

Relief the pain.

Use

INDICATIONS & USAGE SECTION

Used for rheumatic pain, joint pain, low back pain,neuralgia. miscle aches, sprains, and contusions.

Warnings

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

Do not use if there are open wounds on the skin or children.

When Using

OTC - WHEN USING SECTION

Please do not engage in strenuous activities while using this product.

Stop Use

OTC - STOP USE SECTION

Use time does not exceed 8 hours

Keep Oot Of Reach Of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Please place this product in a locker above im away from children.

Directions

DOSAGE & ADMINISTRATION SECTION

Before use, please clean the skin of the affectedarea, peel off the protective film, and apply thispatch directly to the affected area.

Other information

STORAGE AND HANDLING SECTION

This product may cause occasional skin allergies. Ifyou find erythema or edema caused by skin irritationduring use, you should stop using it imediately.The erythema and edema will generally disappear ontheir own. If necessary, you can apply hormone drugsto the skin allergy area for treatment.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Mentha Arvensis Extract, Artemisia Argyi Leaf Extract, Cinnamomum Camphora Linaloolifera Bark/Leaf/Wood Oil, Carthamus Tinctorius (Safflower) Flower Extract,(Cinnamomum Cassia/Magnolia Officinalis) Bark/(Alpinia Officinarum/Angelica Gigas) Root Extract

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1122334455

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
83822-002-012025-07-29C16284748780-13b156c62-2d93-fb37-e063-e6dba90a4e0783822-002
83822-002-022025-07-29C16284748780-13b156c62-2d93-fb37-e063-e6dba90a4e0783822-002
83822-002-032025-07-29C16284748780-13b156c62-2d93-fb37-e063-e6dba90a4e0783822-002
83822-002-042025-07-29C16284748780-13b156c62-2d93-fb37-e063-e6dba90a4e0783822-002
83822-002-052025-07-29C16284748780-13b156c62-2d93-fb37-e063-e6dba90a4e0783822-002
83822-002-062025-07-29C16284748780-13b156c62-2d93-fb37-e063-e6dba90a4e0783822-002
83822-002-072025-07-29C16284748780-13b156c62-2d93-fb37-e063-e6dba90a4e0783822-002
83822-002-082025-07-29C16284748780-13b156c62-2d93-fb37-e063-e6dba90a4e0783822-002
83822-002-092025-07-29C16284748780-13b156c62-2d93-fb37-e063-e6dba90a4e0783822-002

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83822-002-01Soothing patch10 in 1 BAGPATCH101
83822-002-02Soothing patch12 in 1 BAGPATCH121
83822-002-03Soothing patch15 in 1 BAGPATCH151
83822-002-04Soothing patch24 in 1 BAGPATCH241
83822-002-05Soothing patch26 in 1 BAGPATCH261
83822-002-06Soothing patch30 in 1 BAGPATCH301
83822-002-07Soothing patch48 in 1 BAGPATCH481
83822-002-08Soothing patch60 in 1 BAGPATCH601
83822-002-09Soothing patch72 in 1 BAGPATCH721

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83822-002SOOTHING PATCH PATCH [FUZHOU AYIMONG TRADING CO., LTD.]19 package rows20240227_1240eaac-7fc3-a13a-e063-6294a90aa18c.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83822-00283822-002-01, 83822-002-02, 83822-002-03, 83822-002-04, 83822-002-05, 83822-002-06, 83822-002-07, 83822-002-08, 83822-002-09

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
ARTEMISIA ARGYI LEAF2JYC99Q0WZIACT
BORNEOLM89NIB437XACTIB
MENTHOLL7T10EIP3AIACT
CINNAMOMUM CAMPHORA WHOLE0B27814T7XIACT
CINNAMOMUM CASSIA TWIG4UD6VQR2UPIACT
SAFFLOWER4VBL71TY4YIACT

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
1240eaac-7fc4-a13a-e063-6294a90aa18c1240eaac-7fc3-a13a-e063-6294a90aa18c2024-02-25WarningsExact identifier
spl id: 1240eaac-7fc4-a13a-e063-6294a90aa18c
spl set id: 1240eaac-7fc3-a13a-e063-6294a90aa18c

Reported adverse events (FAERS/openFDA)#

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