Otc - Active Ingredient
menthol - usp 12%
Cold Spot
FDA Label NDC 51452-004
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Fabrication Enterprises, Inc. for the product Cold Spot (NDC 51452-004). 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, inactive ingredient, otc - keep out of reach of children, warnings, indications & usage, dosage & administration, otc - purpose, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Inactive Ingredient
aqua (deionized water), arnica montana flower (arnica) extract, chondroitin sulfate, citric acid, eucalyptus globulus oil, glucosamine sulfate,ilex paraguariensis leaf (yerba mate) extract, isopropyl alcohol, menth piperita (pepperment) oil, MSM (dimethyl sulfone) polysorbate-20, SD-alcohol 40B, triethanolamine
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, consult physician.
Warnings
for external use only
avoid contact with eyes
do not apply to open wounds or damaged skin
if symptoms persist for more than seven days, discontinue use and consult physician
keep out of reach of children. if swallowed, consult physician
do not bandage tightly
Indications & Usage
for temporary relief of minor aches and pains of the muscles and joints associated with simple backache, arthritis, bruises, strains and/or sprains.
Dosage & Administration
wipe onto affected area. discard wipe and clean hands after use. do not use more than four times per day.
Otc - Purpose
For temporary relief of minor aches and pains of the muscles and joints associated with simple backache, arthritis, bruises, strains and/or sprains.
Package Label.Principal Display Panel
cold spot point relief wipes
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