Drug Facts Active Ingredients
Menthol 1.25 percent
Nuvalu Ice Therapy Menthol Pain Relieving Gel
FDA Label NDC 76176-239
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Ningbo Liyuan Daily Chemical Products Co., Ltd. for the product Nuvalu Ice Therapy Menthol Pain Relieving (NDC 76176-239). 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 drug facts active ingredients, purpose, use:, warnings:, do not use, when using this product, stop use and ask doctor if, if pregnant or breast-feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Topical Analgesic
Use:
for the temporary relief of minor aches and pains in muscles and joints associated with:
simple backache, strains, sprains, sports injuries, arthritis, bruises
Warnings:
For external use only
Do Not Use
- with other topical pain relievers
- with heating pads or heating devices
When Using This Product
- Do not use in or near eyes
- Do not apply to wounds or damaged skin
- Do not bandage tightly
Stop Use And Ask Doctor If
- condition worsens
- symptoms last more than 7 days or clear up and occur again within a few days
- redness or irritation develops
If Pregnant Or Breast-Feeding,
ask a health professional before use
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Posion Control Center right away.
Directions:
- Clean affected area before applying product
- Adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
Inactive Ingredients:
Water (Aqua), Ethyl Alcohol, Carbomer, Triethanolamine, Camphor, Methylisothiazolinone, Iodopropynyl Butylcarbamate, FD&C Blue No.1
Package Label.Principal Display Panel
Label (103168)
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