Active Ingredient
Menthol 4.0% w/w ...... Purpose: Topical Analgesic
Pain Relief Gel-roll On Gel
FDA Label NDC 73557-333
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 Medical Technology (group) Co., Ltd. for the product Pain Relief Gel-roll On (NDC 73557-333). 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, uses, warnings, flammable, ask a doctor before use if you have, when using this product, otc - do not use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Topical Analgesic
Uses
Temporary relief from minor aches and pains of sore muscles and joints associated with arthritis, backache, strains and sprains
Warnings
For external use only
Flammable
Keep away from excessive heat or open flame
Ask A Doctor Before Use If You Have
Sensitive skin
When Using This Product
Avoid contact with eyes or mucous membranes • Do not apply to wounds or damaged skin • Do not use with other ointments, creams, sprays or liniments • Do not apply to irritated skin or if excessive irritation develops • Do not bandage • Wash hands after use with cool water • Do not use with heating pad or device • Store in a cool dry place
Otc - Do Not Use
• Do not apply to wounds or damaged skin • Do not use with other ointments, creams, sprays or liniments • Do not apply to irritated skin or if excessive irritation develops • Do not bandage • Do not use with heating pad or device
Stop Use And Ask A Doctor If
Condition worsens or if symptoms persist for more than 7 days, or clear up and reoccur
If Pregnant Or Breast-Feeding
Ask a health professional before use
Keep Out Of Reach Of Children
If accidentally ingested, get medical help or contact a Poison Control Center immediately
Directions
Adults and children 12 years of age and older:
Rub a thin film over affected areas not more than 4 times daily; message not necessary
Children under 12 years of age: Consult physician
Inactive Ingredients
Alcohol, Aloe Barbadensis Leaf Extract, Arnica Montana Flower Extract, Boswellia Carterii Resin Extract, Camellia Sinensis Leaf Extract, Carbomer, Camphor, FD&C Blue 1, FD&C Yellow 5, Glycerin, Ilex Paraguariensis Leaf Extract, Isopropyl Myristate, Silica, Triethanolamine, Vitamin E, Water
Questions Or Comments
86-21-31166566
Package Label.Principal Display Panel
Container Label (333 0)
Package Label (333 1)
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