Active Ingredient
Menthol
Csi Cooling Patch
FDA Label NDC 73557-135
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Shanghai Chuangshi Industry Group Co., Ltd for the product Csi Cooling Patch (NDC 73557-135). 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, inactive ingredient, purpose, when using, stop use, ask doctor, ask doctor/pharmacist, 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
Inactive Ingredient
Aloe barbadensis leaf extract
Arnica montana flower extract
Boswellia carterii resin extract
Camellia sinensis leaf extract
Diazolidinyl urea
Dihydroxyaluminun aminoacetate
Glycerin
Iodopropynyl butylcarbamate
Kaolin
Polyacrylic acid
Polysorbate 80
Propylene glycol
Pvp
Sodium polyacrylate
Tartaric acid
Titanium dioxide
Water
Purpose
Pain relief with cold therapy for sore muscles, backaches, and joint pain.
When Using
Temporary relief from minor aches and pains of sore muscles and joints associated with arthritis, backache, strains, sprains.
Stop Use
Buming discomfort or excessive skin irritation develops, condition worsens, or if symptoms persists for more than 7 days, or clear up and occur within few days.
Ask Doctor
Buming discomfort or excessive skin irritation develops, condition worsens, or if symptoms persists for more than 7 days, or clear up and occur within few days.
If pregnant or breast-feeding.
Ask Doctor/Pharmacist
Buming discomfort or excessive skin irritation develops, condition worsens, or if symptoms persists for more than 7 days, or clear up and occur within few days.
If pregnant or breast-feeding.
Keep Out Of Reach Of Children
Keep out of reach of children.
If accidentally ingested, get medical help or contact a Poison Control Center immediately.
Questions
Please contact with us at the phone number +86-21-31166566 or email [email protected] when you have any questions.
Pregnancy Or Breast Feeding
Pregnant or breast feeding women shall follow doctor advice.
Indications & Usage
* Adult and Children 12 year of age and older:
Clean and dry affected area, partially peel back protective film and apply exposed patch to site of pain. Carefully remove remaining film while pressing patch to skin and leave in place for up to 8 hours. Use on affected areas not more than 4 times daily. Wash hands with cool water after use.
* Children under 12 years of age:
Consult physician.
Dosage & Administration
One patch at a time. Use it as needed, no more than 4 times daily.
For external use only.
Dosage Forms & Strengths
This is a patch, tape dosage form.
The active ingredient strength is 5%.
Warnings
For external use only.
Use only as directed.
Store in a cool dry place away from direct sunlight.
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Package
Package (Package)
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