Active Ingredient
Menthol 4%
Pain Relief Cold Therapy Gel 3 Fl Oz
FDA Label NDC 72351-641
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Sotac Pharmaceutical Private Limited for the product Pain Relief Cold Therapy Gel 3 Fl Oz (NDC 72351-641). 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, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Cooling Pain Relief
Uses
Temporary relief from minor aches and pains of sore muscles and
joints associated with •arthritis •backache •strains •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 the 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
Stop Use And Ask A Doctor If
condition worsens, or if symptoms persist for more than 7 days, or clear up and recur
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 (1-800-222-1222) immediately
Directions
• Adults and children 2 years of age and older: rub a thin film over affected areas not more than 4 times daily, massage not necessary
• Children under 2 years of age: consult physician
Other Information
• store in a cool dry place
Inactive Ingredients
aloe vera gel, arnica montana flower extract, articum lappa root (burdock) extract, boswellia carterii resin extract, calendula officinalis extract, camellia sinensis (green tea) leaf extract, camphor, carbomer 934, colloidal silicon dioxide, FD&C blue no.1, FD&C yellow no.5, glycerin, ilex paraguariensis leaf extract, isopropyl alcohol, isopropyl myristate, melissa officinalis (lemon balm) leaf extract, purified water, sorbic acid, tocopheryl acetate, triethanolamine
Questions Or Comments
1-856-357-7321
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