Otc - Active Ingredient
Menthol 4%
Pro Cold Hot Pain Relief Gel Roll-on (plantar Fasciitis) Gel
FDA Label NDC 84165-013
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Guangzhou Zhupuyou E-commerce Co., Ltd for the product Pro Cold Hot Pain Relief Gel Roll-on (plantar Fasciitis) (NDC 84165-013). 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
Topical Analgesic
Indications & Usage
Temporary relieffrom minor aches and pains of sore muscles and joints associated with arthritisbackache, strains and sprains.
Warnings
For external use only
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
do not bandage or use with heating pad or device
Otc - When Using
use only as directed
avoid contact with eyes or mucous membranes
wash hands after use with cool water
store in a cool dry place away from direct sunlight
Otc - Stop Use
You experience pain, swelling or blistering; condition worsens, or if symptoms persist for morethan 7 days,or clear up and occur again within a few days.
Otc - Keep Out Of Reach Of Children
If swallowed accidentally, get medical help or contact with Poison Control Center immediately.
Dosage & Administration
Adults and Children above 12 years old:Rub a thin film over affected areas not more 4times daily; massage not necessary
Children under age of 12: Consult a doctor
Inactive Ingredient
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
Package Label.Principal Display Panel
Label1 (Label1)
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