Otc - Active Ingredient
Active Ingredients: Menthol
Cold Spot
FDA Label NDC 65121-002
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Pure Source for the product Cold Spot (NDC 65121-002). 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, otc - purpose, indications & usage, dosage & administration, 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
Inactive Ingredients: deionized water, arnica, chondroitin sulfate, citirc acid, euclayptus oil, glucosamine sulfate, ilex paraguariesis leaf, isopropyl alcohol, peppermint oil, dimethyl sulfone, polysorbate-20, SD alcohol 40B.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed consult physician
Warnings
Warnings Section: 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 and if swallowed consult physician, do not bandage tightly.
Otc - Purpose
Use: For temporary relief of minor aches and pains of the muscles and joints associated with simple backache, arthritis, bruises, strains and/or sprains.
Indications & Usage
Use: 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
Apply directly to effected area. Do not use more than four times per day.
Package Label.Principal Display Panel
ColdSpot Point Relief Pain Relieving spray, all natural ingredients.
* Please review the disclaimer below.
