Active Ingredient
Lidocaine 4%
Menthol 1%
Therablast Lotion
FDA Label NDC 78663-201
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Releaf Technologies Llc for the product Therablast (NDC 78663-201). 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 ingredient, purpose, uses, warning, otc - keep out of 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
TOPICAL ANALGESIC
Uses
For temporary relief of pain
Warning
For external use only.
Do not use large quantities, particularly over raw surfaces or blistered areas.
When using this product avoid contact with the eyes.
Stop using and ask a doctor if
- the condition worsens
- symptoms persist for more than 7 days
- symptoms clear up and occur again within a few days
- a rash or irritation develops.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions
Adults and children 12 years of age and older: apply to the affected area not more than 3 to 4 times daily.
Children under 12 years of age: do not use, ask a doctor.
Other Information
Protect product from excessive moisture - Avoid storing in direct sunlight - Store with lid tightly closed
Inactive Ingredients
Purified water, Caprylic/Capric Triglycerides, Butyrospermum Parkii (Shea) butter, Cetearyl alcohol, polysorbate 60, Glyceryl stearate, Cyclopentasiloxane, Dimethicone, Phenoxyethanol, Ethylhexylglycerin, me, Extract of Aloe Barbadense leaves, Extract of arnica,
Acrylamide/Sodium Acrylate Copolymer, Mineral Oil, Trideceth-6 Tocopheryl acetate, triethanol amine.
* Please review the disclaimer below.
