Otc - Active Ingredient
Methyl Salicylate 25%
Capsaicin 0.025%
Menthol 10%
New Terocin Lotion
FDA Label NDC 80425-0256
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Advanced Rx Pharmacy Of Tennessee, Llc for the product New Terocin (NDC 80425-0256). 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, otc - purpose, uses, warnings, otc - keep out of reach of children, directions, dosage & administration, indications & usage, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Topical Analgesic
Uses
Temporarily relieves mild aches and pains of muscles or joints.
Warnings
Only for external use.
Do Not Use:
on open wounds, cuts, damaged or infected skin as well as in the eyes, mouth, genitals, or any other mucous membranes.
Consult your physician:
if pain is persistent or worsens or if using any other topical pain products.
Keep out of reach of children.
Consult physician for children under 12.
Otc - Keep Out Of Reach Of Children
Consult physician for children under 12.
Directions
Wash and dry affected area. Shake bottle well before each use and gently rub over area of pain. Use is not recommended more than four times a day. Wash hands immediately afterwards to avoid contact with eyes.
Dosage & Administration
As directed
Indications & Usage
Consult your physician
Inactive Ingredient
Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Borago Officinalis (Borage) Seed Oil, Boswellia Serrata Extract, C12-15 Alkyl Benzoate, Cetearyl Alcohol, Cetyl Alcohol, Diazolidinyl Urea, Dimethyl Sulfone (DMSO), DMDM Hydantoin, Glyceryl Stearate, Lavandula Angustifolia (Lavender) Oil, Methyl Paraben, PEG-100 Stearate, Polysorbate-20, Polysorbate-60, Propyl Paraben, Propylene Glycol, Stearic Acid, Stearyl Alcohol, Triethanolamine, Xanthan Gum.
How Supplied
Bottle of:
120ml NDC: 80425-0256-01
* Please review the disclaimer below.
