Otc - Active Ingredient
Menthol 4%
Goodsense Cooling Pain Relief Gel
FDA Label NDC 50804-297
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Geiss, Destin & Dunn, Inc for the product Goodsense Cooling Pain Relief (NDC 50804-297). 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, dosage & administration, warnings, otc - pregnancy or breast feeding, otc - keep out of reach of children, indications & usage, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Topical Analgesic.
Dosage & Administration
For the temporary relief of minor pain associated with arthritis, simple backache, muscle strains, sprains, and bruises.
Warnings
For external use only.
When using this product keep out of eyes. In case of contact with eyes, flush thoroughly with water, avoid contact with broken skin, do not bandage tightly, and do not use with heating pad.
Stop use and ask a doctor if the condition worsens, rash or irritation develops and lasts for more than 7 days or clear up and occur again within a few days.
Otc - Pregnancy Or Breast Feeding
Ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If the product is swallowed, get medical help or contact a Poison Control Center right away.
Indications & Usage
Adults and children 12 years and older: apply to the affected area, not more than 3 to 4 times a day. Children under 12 years of age: ask a doctor.
Inactive Ingredient
Blue 1, carbomer, isopropyl alcohol, magnesium sulfate, sodium hydroxide, water, and yellow 5.
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