Active Ingredients
Methyl Salicylate 12.5%
Capsaicin 0.025%
Red Hot Ointment
FDA Label NDC 82345-855
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by The Hygenic Company, Llc for the product Red Hot (NDC 82345-855). 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 active ingredients, purpose, uses, warnings, keep this and all drugs out of the reach of children., directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Counterirritant
Uses
For the temporary relief of minor aches and pains of muscles and joints associated with strains, sprains, tendonitis, simple backache, and arthritis. Combined with stretching and calisthenics, Red Hot assists in the warm-up process, especially in cool, damp weather.
Warnings
For external use only.
In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately. Use only as directed. If condition worsens, or if the symptoms persist for more than 7 days, or clear up and occur again within a few days, discontinue use and consult a doctor.
Keep This And All Drugs Out Of The Reach Of Children.
Directions
This product is a strong counterirritant. Apply sparingly. Adults and children 6 years of age and older: apply to affected area not more than 3 - 4 times daily. Children under 6 years of age: consult a doctor.
Other Information
This product is intended to and will cause mild skin irritation. Discontinue use if excessive irritation of skin develops. Avoid getting into eyes or on mucous membranes. Do not apply to irritated or broken skin. Store in a cool, dry place with lid closed tightly.
Inactive Ingredients
Mineral Oil, Paraffin, Petrolatum
Questions?
(800) 345-2231
Package Labeling:
Label8 (Label8)
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