Otc - Active Ingredient
Camphor 80mg/patch
Menthol 24mg/patch
Capsicum Extract 16mg/patch
Pain Relieving
FDA Label NDC 85009-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Changsha Yunhan Hechuang E-commerce Co., Ltd. for the product Pain Relieving (NDC 85009-001). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Topocal Analgesic
Indications & Usage
Uses
For temporary relief of pains
Warnings
Warnings FOR EXTERNAL USE ONLY
Otc - Do Not Use
· Do not use wit a heating pad or apply extecnal heat
· Do not use 1 hour prior to bathing or within 30 minutes after bathing
Otc - When Using
When using this product
· Use only as directed
· Do not get into eyes or on mucous membranes
· Do not apply to wounds,damaged or imitated skin
· Do not bandage or cover with any type of wrap except clothing
· Do not use wit a heating pad or apply extecnal heat
· Do not use 1 hour prior to bathing or within 30 minutes after bathing
Otc - Stop Use
Stop use and ask a doctor if
· Condition worsens
· Severe skin irritation occurs
· Pain persists for more than 7 days
· Symptoms clear up and occur again within a few days
If pregnant or breast-feeding,or if you have sensitive skin,ask a healthcare professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.lf swallowed,get medical helpor contact Poison Control Center right away.
Dosage & Administration
Directions
· Adults and children 12 years and over apply to affected area;change patch 1 to 2 times daily
· Children under 12 years,consult doctor before use
· How to apply:
· Clean and dry affected area
· Cut open pouch and remove patch
· Remove protective film and apply directly to area of pain
· Apply to affected area not more than 3 times daily
· Wash hands with soap after applying patch · Reseal pouch containing unused patches
Storage And Handling
Other Information This product may cause allergic reaction on some individuals.Store in cool dry place away from direct sunlight.
Inactive Ingredient
Inactive Ingredients:Aluminium glycinate,eucalyptus oil,glycerin,hydrotalcite,kaolin,mentha oil,polysorbate 80,polyacrylic acid solution,propylene glycol,sodium carboxymethylcellulose,sodium polyacrylate,sorbitol solution,water
Package Label.Principal Display Panel
85009-001-01 (85009 001 01)
85009-001-02 (85009 001 02)
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