Hot Spot
FDA Label NDC 65121-010

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 Hot Spot (NDC 65121-010). 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

Otc - Active Ingredient

Active Ingredients: Capsaicin

Inactive Ingredient

Inactive Ingredients: deionized water, oil of Cassia, chondroitin sulfate, glucosamine sulfate,Glycrrhiza Glabra (licorice) extract, Carbomer, Triethanolamine,  polysorbate-20, Phenoxyethanol, Ethylhexylglycrine.

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

HotSpot Point Relief Pain Relieving gel, all natural ingredients.

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