Active Ingredient
Borneol 5%
Soothing Patch
FDA Label NDC 83822-002
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Fuzhou Ayimong Trading Co., Ltd. for the product Soothing Patch (NDC 83822-002). 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 ingredient, purpose, use, warnings, do not use, when using, stop use, keep oot of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Relief the pain.
Use
Used for rheumatic pain, joint pain, low back pain,neuralgia. miscle aches, sprains, and contusions.
Warnings
For external use only.
Do Not Use
Do not use if there are open wounds on the skin or children.
When Using
Please do not engage in strenuous activities while using this product.
Stop Use
Use time does not exceed 8 hours
Keep Oot Of Reach Of Children
Please place this product in a locker above im away from children.
Directions
Before use, please clean the skin of the affectedarea, peel off the protective film, and apply thispatch directly to the affected area.
Other Information
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
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
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