Otc - Active Ingredient
Acitve ingredients: capsaicin
Hot Spot
FDA Label NDC 51452-010
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Fabrication Enterprises for the product Hot Spot (NDC 51452-010). 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
Inactive Ingredient
aqua (deionized water), carbomer, cassia oil, choldroitin sulfate, ethylhexylglycerine, glucosamine sulfate, glycrrhiza glabra (licorice) extract, phenoxyethanol, polysorbate-20
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
Otc - Purpose
external analesic
Indications & Usage
for temprorary 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 affected area. do not use more than four times per day.
Package Label.Principal Display Panel
* Please review the disclaimer below.
